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Product warranties by orthopaedic surgery companies. Quality control or a new fad?
∗Corresponding author: Andrew R. Grant. Agrant8@nebh.org
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Received: ,
Accepted: ,
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.
Abstract
Abstract
Product guarantees are known to the manufacturing industry, however warranties have been rare in Orthopaedic surgery. Over the last 10 years, select manufacturers of implants have instituted warranties of varying scope, length, and reimbursement. This phenomenon prompted us to investigate the landscape of warranties in Orthopaedics and compare that to other medical industries to better inform their impact on patient care.
We conducted a systematic review of patient access material of over 120 Orthopaedic manufacturers including that of the Top 25 grossing companies of 2022 to identify the prevalence and scope of these warranties.
We identified eight companies that offer a warranty on implants. The expiration time for the implant warranties ranged from one year to lifetime. The scope of the warranties ranged from coverage of a one-time component replacement to outcome-based guarantees that cover any complications and revisions that may result from the surgery.
While the use of warranties remains uncommon in orthopaedics, their utility is expanding and evolving. Contemporary warranties appear to have a focus on enhancing product-marketability and improving quality-control.
Keywords
Warranties
Guarantees
Arthroplasty
Spine
Trauma
Manufacturers
Industry
1 Introduction
The term warranty dates back to the mid 14th century Old North French term warantie.1 Similarly, “guarantee” dates back to the 1590s via its adaptation of garantie2. In the United States, warranties are governed by State consumer protection offices and the Federal Trade Commission.3 For implied warranties such as “warranty of merchantability” the seller promises the product will function as intended. In contrast, written warranties are statements with specific promises in the event of failure, dissatisfaction etc. These conditions ensure the integrity of a product for a defined period with the promise of replacing, repairing, or covering complete or partial cost of the product.
Warranties are ubiquitous in industries outside of medicine including the automobile, appliance, and technological industry, however the presence of warranties in medicine is inconsistent. Specifically, no entity in orthopaedics offered this type of agreement until 2012 when Zimmer Biomet announced a lifetime warranty of the Oxford® partial knee implant.4 This was the first in the industry, and while some companies have followed suit, this is not common practice. In contrast, warranties on implanted medical devices have been adopted in other fields of medicine such as plastic surgery, oral surgery, and cardiology.5–8 In cardiac medicine, warranties for implanted defibrillators have been offered for more than 30 years.9
This narrative review evaluates the status and extent of guarantees in Orthopaedics and discusses the potential driving forces behind this trend. This review's purpose is to inform surgeons and their discussions with patients.
2 Methods
We conducted a detailed evaluation of public access material of 121 manufacturing companies that design products for orthopaedic surgery. The review was initiated with an exhaustive Google search using terms such as “warranty for implants in orthopaedics” or “guarantee for orthopaedic implants”. Afterwards, a large sample of orthopaedic implant companies was collected including the Top 25 grossing orthopaedic companies of 2022 and a filtered search for companies manufacturing “component parts” for “joint replacement” within ORTHOWORLD Inc's supplier directory.10 Additionally, we included companies listed in Becker's Spine Review's“35 Orthopaedic and Spine Device Companies to Know”.11 Each company's website information regarding warranties' presence, length, terms and claim coverage was reviewed in detail.
3 Results
We identified 121 manufacturing companies. Eight were excluded as their website information indicated they did not manufacture surgical implants. Of the remaining 113 manufacturers, eight offered a warranty for an implanted device. One healthcare system has a partnership with a manufacturer to cover patient costs for complications or revisions following surgery. Another healthcare system provided a similar guarantee without a commercial partnership. Additionally, 39/113 companies listed terms of sale information on their website regarding short term guarantees against delivery of a product with manufacturing defects. These timeframes were either not provided or ranged from 7 days–2 years. Of these sites, 32/39 had disclaimers against any unspecified or implied warranties. Finally, 45/113 sites provided no information regarding warranties, disclaimers, or terms of use.
4.1 Joint arthroplasty
4.1.1 Lifetime warranties
Two manufacturing companies offered lifetime warranties on at least one arthroplasty implant product (Table 1).
| Company | Warranty | Product (s) | Coverage | Terms/Eligibility |
| Zimmer Biomet | Lifetime Limited Warranty | Oxford Medial Partial Knee Replacement System | One-time free complete replacement of product or component | If only a component needs to be replaced, such replacement does not count towards the limitation. |
| Medacta (and Geisinger) | Lifetime Warranty | All primary hip, primary knee, primary shoulder, lumber spine fusion and revision knee replacements. | Medacta: lifetime coverage for replacement of total hip, knee and revision knee implants | Geisinger Health Plan member, had surgery at Geisinger facility with Medacta-deemed “master surgeon of its implants and techniques”, and remain in care of a Geisinger provider. |
Zimmer-Biomet (Warsaw, IN)- instituted a lifetime warranty in 2012 for the Oxford® Medial Partial Knee Replacement system including the bearing, femoral component and tibial base plate. They state this is “the only Lifetime Partial Knee Implant Replacement Warranty in the U.S”. The warranty states that for the life of the patient, there is a guarantee of a one-time free replacement of the product or a component thereof, manufactured and distributed by Zimmer-Biomet only. If one component of the product needs to be replaced, this is not counted towards the limitation. The replacement does not extend to guides, products, instruments, systems, devices, surgical or professional costs/fees of service. No warranty is provided for replacement products. This warranty is limited to components implanted in the United States.12
Medacta (Castel San Pietro, Switzerland)- In partnership with the Geisinger Health system (Pennsylvania, USA) and Geisinger Health Plan, Medacta offers a “lifetime guarantee” for all primary hip, primary knee, primary shoulder, and revision knee replacements. This warranty applies to all patients with a qualifying Geisinger Health Plan, who had their surgery at a Geisinger facility with a surgeon who Medacta agrees is a “master surgeon of its implants and techniques”, and who remain in the care of a Geisinger provider. Geisinger's warranty guarantees outcomes and covers all costs of any revision or complication (e.g. DVT, PE) for two years. In conjunction, Medacta offers a lifetime guarantee for their total hip, knee and revision knee implants. This partnership appears to be the first and only in Orthopaedics.13
Similarly, Virginia Mason (Seattle, WA), a nonprofit regional healthcare system, offered a bundled service contract to insurance companies and businesses to cover the “full range of care including diagnosis, surgery and rehabilitation”.14 This plan covers only services and complications from care delivered by Virginia Mason and does not cover complications related to implant or device failure. Information regarding this program is no longer available on the network's website. (Table 2).
| System | Warranty | Product (s) | Coverage | Terms/Eligibility |
| Geisinger (with Medacta) | 2-year surgical outcome guarantee | All primary hip, primary knee, primary shoulder, lumber spine fusion and revision knee replacements. | All costs of any revision or complication (e.g. DVT, PE) within the first two years. | Geisinger Health Plan member, had surgery at Geisinger facility with Medacta-deemed “master surgeon of its implants and techniques”, and remain in care of a Geisinger provider. |
| Virginia Mason | Bundled service contract to insurance companies and businesses (unknown length) | THA and TKA procedures | Full range of care including diagnosis, surgery and rehabilitation and cost of complications | Unclear if still offered |
4.1.2 Time-constrained warranties
Two companies offered a time-constrained warranty for at least one arthroplasty implant (Table 3).
| Company | Warranty | Product (s) | Coverage | Terms/Eligibility |
| Zimmer Biomet | 10-year Bone Cement Warranty | Biomet Bone Cement R for primary partial and TKA | Replacement bone cement and associated partial/TKA components that failed via aseptic loosening | One complete replacement of the product, additional costs not covered, hospitals and facilities must be enrolled to be eligible. |
| 2-year Total Hip & Knee Warranty + Program | Any Zimmer Biomet THA or TKA primary implant | Same or comparable TKA/THA implants and qualifying add-on technology where qualifying revision is required | No exclusion criteria, potential additional $2500-$7500 credit if other Zimmer Biomet products were used in primary procedure. | |
| 3- year ROSAdvantage | Persona® Knee implants ROSA® Knee System and Bactisure™ Wound Lavage were used in primary procedure | $2500 Credit towards any Zimmer Biomet Products | Revision in the event of failure or infection of a covered implant. | |
| Conformis | 5-year warranty | Conformis knee replacement | $3000 reimbursement | Platinum service upgrade feature. If revision is required within 5 years of index Conformis knee replacement. |
Zimmer Biomet (Warsaw, IN)- offers three time-constrained warranties. For hospitals enrolled in their Bone Cement Warranty program, a 10-year warranty is offered for the bone cement utilized in primary partial and primary knee replacement implants.15 Additionally, this warranty covers the cost of a one-time replacement of components for any associated partial and primary knee replacement due to aseptic loosening.
The Total Hip & Knee Warranty + Program is a 2-year warranty for all Zimmer Biomet total hip and knee implants and associated technology. The company offers coverage of component replacement in the event of failure leading to revision and states that the program has no exclusion criteria.16 There are tiered benefits for refunds of purchase credits for procedures in which Zimmer Biomet technologies were used scaling to $7500. ROSAdvantage, a similar program, provides a purchase credit of $2500 and coverage of a qualifying revision within 3 years of the initial surgery if products are used in accordance with protocols.17
Conformis (Bellerica, MA)- offers an optional warranty obtained by upgrading to the Platinum Services program.18 This 5-year warranty offers reimbursement for a revision surgery on the replacement of up to $3000. There is no information regarding geographic restrictions for this offer.
5 Statements with insufficient information
Precision Coating guarantees that they will apply coatings to orthopaedic implants per manufacturer's standards and that it will adhere to the substrate.19 There is no further information provided.
5.1 Orthopaedic spine implants
5.1.1 Lifetime warranties
Two companies offered a lifetime warranty for at least one orthopaedic spine implant product (Table 4).
| Company | Warranty | Product (s) | Coverage | Terms/Eligibility |
| Medicrea | Lifetime Warranty | UNiD™ Thoracolumbar and Cervical Rods and all associated MEDICREA components | UNiD™ Lab services, patient-specific UNiD™ Rod replacement and all associated MEDICREA implant components required to treat any patient undergoing a revision surgery. | Affiliated benefit of UNiD™ Lab Premier Service. Unclear if program is active. |
| Medacta (and Geisinger) | Lifetime Warranty | All primary hip, primary knee, primary shoulder, lumber spine fusion and revision knee replacements. | Medacta: lifetime coverage for replacement of total hip, knee and revision knee implants | Geisinger Health Plan member, had surgery at Geisinger facility with Medacta-deemed “master surgeon of its implants and techniques”, and remain in care of a Geisinger provider. |
Medicrea (Lyon, France)- now owned by Medtronic, began offering a lifetime warranty in 2016 for UNiD™ Thoracolumbar and Cervical Rods and associated MEDICREA components implanted in the United States.20 This warranty is an affiliated benefit of the Premier Service, which includes real-time support of biomechanical engineers and preoperative planning and post-operative analytics and is available to all countries using the technology. Of note, this information was reported in several press releases at the time of the launch, but it was not found on Medicrea or Medtronic's current iterations of its website during our search.
Medacta (Castel San Pietro, Switzerland)- In March 2023, Medacta expanded its partnership with the Geisinger Health system and Geisinger Health Plan to include a lifetime guarantee for spinal fusion procedures.21 The same parameters apply to this program as the joint arthroplasty program.
5.1.2 Time-constrained warranties
We identified four companies that offered a time-constrained warranty on at least one of their products (Table 5).
| Company | Warranty | Product (s) | Coverage | Terms/Eligibility |
| Medtronic | 9-year warranty | Intellis™ Spinal Cord Stimulator | Replacement of Battery | No further information available. |
| Titan Spine | 5-year warranty | Any eligible Titan spinal interbody fusion device if revision surgery is required within the five year warranty period | One-time free replacement | If revision is required or if Endoskeleton interbody fusion device delaminated or generated particulate debris during implantation. Unclear if program is active. |
| Aesculap | Unknown length, surface-wear warranty | Plasmapore XP surface (spinal interfusion bodies) | Device replacement | If a reoperation occurs due to a “clinically relevant delamination or the generation of impaction debris or a CT or MRI artifact caused by the device that impedes a physician's ability to visualize adjacent anatomy. Unclear if program is active. |
| SI-Bone | 1-year warranty | Any iFuse Implant™ | Replacement of implant and any additional iFuse screws during revision | Revision in any case except where failure resulted from failure of patient to follow post-operative instructions provided by surgeon. No replacement product or credit will be given if fewer than three (3) iFuse Implants per side were used in the index procedure. Revision must be completed under a new hospital admission. NO other product aside from SI Bone product can be used in revision procedure. |
Medtronic (Dublin, Ireland)- offers a 9-year warranty on their Intellis™ Rechargeable Spinal Stimulator.22 The warranty appears to be predicated on a 95 % battery life at 9 years. There is no further information on the website, but they offer an email contact for further inquiry.
Titan Spine (Meqoun, Wisconsin)- From 2016 to 2019, offered a 5-year warranty for a one-time free replacement of any eligible Titan spinal interbody fusion device for required revision surgeries performed within the five-year warranty period. This agreement was amended in 2016 to add coverage of a replacement if the company's Endoskeleton interbody fusion device delaminated or generated particulate debris during implantation. There was no information regarding geographic restrictions of this warranty. The company was purchased by Medtronic and the status of this agreement is unknown, as it was not displayed on Medtronic's website.23
Aesculap (Center Valley, PA)- began offering a warranty in 2017 on its Plasmapore XP surface, a component of spinal interfusion bodies. The terms of sale states they will replace the device if reoperation occurs from “clinically relevant delamination or the generation of impaction debris or a CT or MRI artifact caused by the device that impedes a physician's ability to visualize adjacent anatomy.” The warranty is backed by the governing laws of the state of Pennsylvania which may indicate geographic restriction.24 It is unclear if the warranty is still offered. As of 2019, this warranty was not listed under product-specific warranties offered by the company.25
SI-Bone (Santa Clara, CA)- offers a 1-year warranty on a one-time replacement of any iFuse Implant™ at no additional cost if revision is completed at the same facility or system facility during a separate admission.26 The revision can be for any reason except where the “failure resulted [from] failure of the patient to follow post-operative instructions provided by the surgeon”. This covers any additional or replacement implants required during the revision procedure to fixate the index joint. No replacement or credit is given if less than 3 implants per side were used in the index procedure. Of note, the warranty is administered by a different entity and claimed with a separate procedure in Australia.
5.2 Orthopaedic trauma, hand & upper extremity, arthroscopy
For these subspecialties, the available warranties are limited to protection against implant manufacturing defects upon delivery or coverage of surgical instruments. Smith and Nephew (London, UK) offers replacement of orthopaedic reconstruction and trauma products within 180 days of purchase for customers in the U.S., Canada, and European Union.27
Arthrex (Naples, FL) offers warranties on various consoles and instruments including a lifetime warranty on Hand Instruments for U.S. customers.28
CONMED offers a 7-year guarantee for an arthroscopic system that warrants against steam reducing visibility. Of note, the link to further information regarding this warranty is no longer functional; therefore no further information could be discerned.29
6 Discussion
Outcome guarantees and implant warranties are relatively new in the Orthopaedic industry. Based on our search 8/113 companies offer a warranty on implants. There are more than 1000 companies worldwide; however, we did not identify another warranty after the 60th website reviewed. Therefore, we estimate the incidence of these warranties is <1 %.
The effect of guarantees has been documented in other industries.30 In 1988, the Harvard Business Review published on the power of guarantees in marketing. In their example, an extermination company charged ten times more than its competitors, but had a “disproportionately high market share in its operating areas”. Additionally, the company only paid $120,000 for claims compared to its $33 M sales in 1986. There is currently no data available for the financial impact of orthopaedic warranties.
The clinical utility of these warranties is unclear. Of the ten implant warranty policies highlighted, seven only cover the replacement the component and do not extend to any other cost such as instruments, hospital costs, co-pays, or other related expenses associated with a revision surgery.16,20,26 Therefore, the indicated revision implant or significant additional costs linked to care may not be covered under the warranty. In the case of Zimmer Biomet's unicompartmental prosthesis, it's important to note that revision of unicompartmental knee arthroplasty is more commonly a conversion to a total knee arthroplasty.31,32 This supports the idea that warranties may be driven by marketability rather than a desire to provide clinical or financial benefit to patients.
The partnership between Geisinger and Medacta may be the exception to this statement as their policy covers revision costs and complications that may arise from surgery. They state that they share responsibility for clinical outcomes of Hip Fractures, THA, TKA, and Lumbar Spine procedures, and intend to prompt conversation about accountability for complications.33
Implant warranties are offered in other fields including cardiology, plastic surgery (breast implantation), and dentistry.5–8 In the dental industry, multiple companies offer a lifetime warranty on their implants with free replacements.7 Dental implants estimated longevity is similar to that of orthopaedics'.34,35 It is currently unclear what drives differences between fields, but it may be because the dental and plastic surgery industries are more likely to be “out of pocket” procedures. While orthopaedics is being increasingly viewed as a “consumer industry”, joint arthroplasty and spine procedures are covered by insurance.36 This may have limited warranties' benefit which may explain why they aren't as prevalent as some initially predicted.
Interestingly, some Orthopaedic companies offer warranties for non-surgical products. For example, Stryker offers an outcomes-based partnership for one of their software-enhanced hospital beds with a money-back guarantee to reduce pressure injuries by 30 %, surface rentals by 50 % and falls by 50 %.37 This type of program is likely predicated on the fact that hospitals carry the burden of this expense as well as the benefits of the promised improved outcomes.
Of note, four of the eleven warranties may no longer be in effect (Table 1). In a recent study, it was found that many advertised products in the field of Orthopaedics are unavailable after 10 years; often without announcement.38 This phenomenon is present in our study and is a noteworthy consideration. Companies may be able to gain exposure via warranty advertisement without repercussions of negative advertisement upon discontinuation.
For surgeons, it is important to be aware of warranties as options and entities that patients will inquire about. All warranties currently offered in Orthopaedics provide a level of marketability but do offer quality-control and financial advantages if replacement secondary to failure is the indicated procedure. We have presented the available information here to inform surgeons’ decisions and discussions with patients about implant choices.
6.1 Limitations
Our search did not encompass every Orthopaedic manufacturer. The list of the top 100 Orthopaedic companies is pay-walled information from market analyses and therefore was not utilized. The search was limited to web-based material and does not guarantee identification of all agreements offered by implant manufacturers.
7 Conclusion
Outcome-based guarantees and quality-control warranties remain uncommon in the Orthopaedic industry. Since 2012, multiple companies have offered warranties, while others may no longer be offered. There is a lack of consistency and regulation in this area. A deeper analysis is needed to assess their financial impact. There remains a need for systematic oversight of this process to ensure documents are up-to-date and in alignment with current evidence-based interventions. We hope this review prompts further investigation and discussion surrounding the impact of these guarantees and informs Orthopedists when discussing this topic in the clinical setting.
Funding/sponsorship
There was no external funding for this study.
The author's disclosures are as follows
Ayesha Abdeen, MD.
AAOS: Board or committee member.
American Association of Hip and Knee Surgeons: Board or committee member.
Brixton Biosciences: Stock or stock Options.
DePuy, A Johnson & Johnson Company: Paid consultant,
Smith & Nephew: Paid consultant,
Eric L Smith, MD.
3 M: Research support
AAOS: Board or committee member.
American Association of Hip and Knee Surgeons: Board or committee member.
Conformis: IP royalties; Paid consultant; Stock or stock Options.
DePuy, A Johnson & Johnson Company: Paid consultant.
Pacira: Paid presenter or speaker.
Andrew R Grant: Nothing to disclose.
Nicholas Pagani MD: Nothing to disclose.
Patient consent
Not applicable.
Institutional Ethical Committee approval
Not applicable.
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