DePuy Attune Knee Studies
In the Journal of Knee Surgery (June 2017) nine prominent orthopedic surgeons—the authors– reported an unusually high-rate of premature failures of the Attune Knee System. The surgeons attributed the failures to the de-bonding of the tibial implant-cement interface. In other words, the surgeons discovered that the “glue” typically used to hold an implant in place does not “stick” adequately to the tibial component of the Attune Knee System. As a result, the tibial component of the Attune Knee System loosens, and the entire knee replacement is destabilized.
The authors reviewed clinical, radiographic and intraoperative findings for patients who received the Attune system and later required revision surgery. They found 21 reports of tibial loosening at the implant-cement interface to MAUDE in the past two months alone, along with “numerous other tibial failures” without the mechanism for failure specified.
Attorneys for Plaintiff Joyce Rogers cited in her lawsuit the Journal of Knee Surgery , titled “High Rate of Early Failure of Tibial Component in ATTUNE total Knee Arthroplasty System at Implant-Cement Interface.”
A study in the Journal of Arthroplasty(Jan 2017) titled “Tibial Tray Thickness Significantly Increases Medial Tibial Bone Resorption in Cobalt–Chromium Total Knee Arthroplasty Implants” suggests that knee replacements may be associated with a high rate of baseplate loosening and failures due to thicker cobalt-chromium tibial trays that increase the risk of bone loss.
In its Article Assessment , DePuy attempts to discredit the article, which concluded that “high rates of ATTUNE Device failures were occurring due to debonding at the tibial baseplate-cement interface.” DePuy argues that “the article is a retrospective study with no control”. Ironically, Attune Knee was brought to market via the 501(k) process—without clinical controls.
DePuy conducted its own study(May 2017) and concluded that its “four-year revision rate is lower than total knee class”.
DePuy Attune Knee and the FDA
The authors also reviewed the FDA’s MAUDE database (April 2017) for reports of aseptic failure and found it “not consistent and competing companies cannot provide data on the revised components”.
Although they found multiple reports of tibial component loosening, the authors believe these incidences “might be underreported, as company representatives from another companies cannot report to MAUDE database”.
(Those reports may be the tip of the iceberg. Madris Tomes, a former FDA employee who worked on the FDA’s MAUDE database and formed her own company called Device Events, says there are major flaws in the database.)
The 501(k) Process
Section 510(k) of the Food, Drug and Cosmetic Act provides a mechanism for device manufacturers to obtain accelerated FDA clearance for products that are shown to be “substantially equivalent” to a product that has previously received FDA approval. The process requires device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance of introduction to the market. This is known as Premarket Notification also called PMN or 510(k). This approval process allows the FDA to determine whether the device is substantially equivalent to a device already approved for marketing.
In December 2010, DePuy received FDA clearance of the DePuy Attune”‘ Knee System under the “510k” notification process. The basis for FDA clearance was substantial similarity to several prior devices. Including the DePuy P.F.C. SIGMA Knee System. Consequently, DePuy received FDA approval with only very limited, if any testing of its new Attune Knee Replacement.
FDA MAUDE Database
Beginning in 2013, failure reports were submitted to the FDA’s Manufacturer and User Facility Device Experience (MAUDE), a database that houses medical device reports submitted by reporters such as manufacturers and hospitals. But the reporting is voluntary. The FDA itself admits that its assessment of medical device safety is inconclusive because manufacturers and hospitals often submit incomplete, inaccurate, untimely, unverified, or biased data.
Still, MAUDE reports an extremely high incidence of aseptic loosening at the tibial baseplate of the ATTUNE Device resulting in subsequent revision surgeries. As of June 2017, the database includes about 1,400 reports of failure, 633 of which resulted in revision surgeries.
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