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Metal-on-metal hip replacements have experienced an unusually high failure rate, as high as 43% for one model. Several models have been subject to voluntary recalls, and Great Britain’s National Health Service recently announced a ban.
Metal-on-metal hip replacements were introduced under a belief that they would be more durable than other types of implants. However, metal debris—usually chromium or cobalt—can be released into the patient’s body as the implant’s ball and socket rub against each other. This can lead to hip replacement complications such as inflammation, groin pain, dead tissue, and bone loss, and often forces patients to have a procedure to replace the implant, known as hip revision surgery.
The US, UK, Australia and Canada have each issued health warnings related to the failure of metal-on-metal hip replacements.
FDA Hip Replacement Approval Process
The FDA does not require clinical trials for orthopedic implants if the device is similar to one already on the market. This ostensibly allows companies to make incremental changes to their devices without resubmitting them for approval. In the case of DePuy’s ASR (Articular Surface Replacement) XL Acetabular implant, that process allowed an unapproved joint design to be incorporated into a hip replacement and the device released to the market without clinical testing.
A 2013 article in the New England Journal of Medicine neatly illustrates the flaws in the 510(k) approval system by tracing the ancestry of the ASR XL Acetabular hip system.
There were numerous problems with the implant’s approval process:
- Individual aspects of the device design were compared to different predicate devices (known as a split predicate); these specific features had never been used together in a single device.
- Several predicate devices (in a “family tree” of no fewer than 95 devices) were discontinued well before the ASR’s clearance due to high revision rates. However, under the rules of the 510(k) process, DePuy needed only to prove that the ASR was no less safe than those devices–an extremely low standard, since the predicate devices weren’t actually safe to begin with.
- The ASR’s approval could ultimately be traced back to devices that were introduced before the 1976 Medical Device Amendments, which set out modern standards of clinical testing, including the 510(k) system. In other words, no predicate device to the ASR actually received adequate human testing.
In January of 2013, the FDA proposed changes to existing rules that would require approval of new metal-on-metal hip replacements prior to their release.
DePuy ASR Hip Implant Recall
In late 2009, DePuy, a division of Johnson & Johnson, began to remove its ASR implants from the shelves, citing flagging sales. Then, in August 2010, the company issued a recall due to the device’s high failure rate, approximately 12% after 5 years according to a study of UK patient registries. A further study, released in 2013 by the UK’s National Institute for Health and Care Excellence (Nice), found that the failure rate of the DePuy implants reached 43% after 9 years.
DePuy had been receiving complaints about the devices from physicians and patients for years before the recall, which it generally blamed on surgical error.
NHS Hip Replacement Ban and Other Recalls
In October 2013, based on the Nice study, Great Britain’s National Health Service drafted new rules to ban the use of all hip implants with a failure rate above 5%. The ban will affect virtually every model of metal-on-metal hip implant currently on the market.
Other hip-replacement manufacturers in the United States have issued voluntary recalls. In 2012, Smith & Nephew recalled the metal liners in its R3 Acetabular System, citing high failure rates based on evidence from the UK and Australia. Also in 2012, Stryker recalled its Rejuvenate and ABG II modular-neck hip stems due to high rates of corrosion and the possibility of tissue damage and inflammation.
What To Do If Your Hip Implant Is Recalled
When a company recalls a hip implant, it generally issues a letter, to physicians, to insurance companies, or directly to patients. The FDA also maintains a searchable database of recalled medical devices and announces device recalls when they happen. Recall letters will often suggest a course of action and explain how a company will compensate individuals (e.g. through paying for revision surgery).
If your hip implant is recalled, speak to your doctor immediately to help decide on the best course of action. As you make your decision, it’s important to keep in mind that device manufacturers may structure recalls in such a way as to limit their legal liability, or ask patients to waive their right to privacy or to a lawsuit. A recall may require that a patient takes a specific course of action in order to receive compensation, thus limiting treatment options.
DePuy in particular has been criticised for its handling of the ASR recall, for which it uses a third party, Broadspire Services Inc. (Stryker also employs Broadspire.) Critics have accused DePuy of trying to take advantage of patients who don’t fully understand their legal rights. Broadspire has also asked patients to pay for revision surgery out of pocket before considering reimbursement claims.
The terms of a recall may very well be right for you. Before agreeing to anything, however, consult your lawyer to make certain your legal rights are protected.
Ongoing Hip Lawsuits
In addition to the litigation that DePuy is still involved with, other metal-on-metal hip replacement manufacturers are facing lawsuits related to the high failure rate of their devices.
In 2012, Stryker voluntarily recalled its Rejuvenate and ABG II hip implants, citing the risk of corrosion. The company estimates that costs related to the recall and accompanying litigation could climb as high as $1.13 billion.
Zimmer is in early stages of litigation over two modular implants that utilize its Kinectiv Technology, the M/L Taper Hip Prosthesis and CLS Brevius Stem.
Wright Medical is facing lawsuits related to its Conserve Plus metal-on-metal implant system, many of which have been consolidated into a multidistrict litigation (MDL) in Georgia. It has not issued a recall for its devices.
Biomet is being sued over its M2A-Magnum hip replacement system. The lawsuits have been consolidated into an MDL in Indiana. Biomet has not issued a recall.
Between 2009 and 2012, Smith & Nephew recalled the metal liners in its R3 Acetabular System, citing evidence of high failure rates in UK and Australian patient registries. As of November 2013, extensive litigation has not been filed against the company. A judge in Illinois recently dismissed a suit based on a lack of specificity in the plaintiff’s allegations.
- FDA Activities: Metal-on-metal hip implants. Retrieved from FDA website November 21, 2013
- Recalls: Metal-on-metal hip implants. Retrieved from FDA website November 21, 2013
- FDA. Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices, docket no. FDA-2011-N-0661, January 18, 2013
- Smith & Nephew (2012). R3 Acetabular System Metal liner component: Frequently asked questions for health care professionals. Retrieved November 21, 2013
- Concerns about metal-on-metal hip implants. Retrieved from FDA website November 21, 2013
- Donnelly, L. (2013, October 25). NHS hospitals to be banned from fitting metal-on-metal hip replacements after high failure rate. The Telegraph [London]. Retrieved November 21, 2013
- Rattue, P. (2012, March 15). Metal-On-Metal Hip Replacements - Failure Rates Are High. Medical News Today. Retrieved November 21, 2013
- DePuy Orthopaedics (2010). https://www.depuysynthes.com/about/news-press/qs/depuy-orthopaedics-voluntarily-recalls-asr-hip-system---depuy. Retrieved November 21, 2013
- Farrell, G., & Voreacos, D. (2011, March 9). J&J Hip Failure Rate as High as 49 Percent, U.K. Doctors Say. Bloomberg. Retrieved November 21, 2013
- Meier, B. (2010, December 16). The Implants Loophole. The New York Times. Retrieved November 21, 2013
- Meier, B. (2010, March 9). With Warning, a Hip Device Is Withdrawn. The New York Times. Retrieved November 21, 2013
- Meier, B. (2010, March 3). Concerns Over ‘Metal on Metal’ Hip Implants. The New York Times. Retrieved November 21, 2013
- Smith, A., Dieppe, P., Vernon, K., Porter, M., & Blom, A. (2012). Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales. The Lancet, 379(9822), 1199 - 1204. Retrieved November 21, 2013
- Stryker (2012). Rejuvenate Modular / ABG II Modular-Neck Stem Voluntary Recall. Retrieved November 21, 2013
- Clarke, T. (2011, August 22). Insight: Depuy's handling of hip recall sparks questions. Reuters. Retrieved January 14, 2014
- Singer, S. (2013, March 30). Boynton orthopedic surgeon removes recalled hips; ‘wearing us down’. The Palm Beach Post. Retrieved January 14, 2014
- Ardaugh, B.M., Graves, S.E., & Redberg, R.F. N Engl J Med 2013; 368:97-100 January 10, 2013. DOI: 10.1056/NEJMp1211581