DePuy Knee Recalls
As of early 2018, there hasn’t been a recall on the total DePuy Attune knee system. However, a recall was issued involving a device used during knee replacement surgery—a small coil that could become detached and end up being left inside a patient.
The recall in June 2015 involved 3,474 units and was issued by the FDA for an Attune Knee Tibial Articulation Surface instrument.
(Surgeons must measure the patient’s bones and range of motion before a knee implant can be inserted, to properly calibrate the device. A “trial” implant is used before any holes are drilled into the bone and with that trial implant comes a Balseal, a small wire spring coil used in the range of motion testing to aid in tibial location prior to drilling peg holes. But the Balseal easily became damaged and fell out during use, so the coil was able to enter the surgical site during the knee replacement surgery and remain in the patient if the surgeon forgot or was unaware that it had detached.)
From 2003 until 2013, DePuy recalled 277 devices or components, four of which were Class I recalls, or products with flaws that could seriously harm patients, according to Consumers Union. Most products were Class II recalls, which the FDA describes as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
In 2011 the FDA sent DePuy a warning letter, stating the company was marketing and selling several products that had not received approval; that several devices or components had been altered; and were currently misbranded as safe and effective. (DePuy asserted their devices could be approved through the 510(k)). As a result, DePuy voluntarily recalled a number of its knee replacement components.
DePuy Attune Knee History
1895: DePuy Orthopaedics. Inc. was founded. It now purports to be a worldwide leader in the design and manufacture of orthopedic devices and supplies, including hip, knee, cement and other products used in orthopedic procedures.
1977: DePuy introduced the LCS Complete Knee System
1984: DePuy introduced the P.F.C. Total Knee System. According to DePuy, clinical studies have proven the success of the P.F.C. design, with 92.6 percent survivorship at 15 years.
1996: Based on this clinical success– according to DePuy– the company introduced the DePuy Synthes P.F.C. SIGMA System
2010: The DePuy Attune Knee System was cleared by the FDA through the 510(k) program, which allows medical devices to come to market without the benefit of human clinical trials if a manufacturer can show that it is substantially equivalent to a device that was previously cleared through the FDA’s standard premarket approval process. That similar device was the DePuy SIGMA.
June 2015: DePuy announced a recall for the Attune Articulation Surface Component after finding a spring coil could break off and enter the surgical site without the surgeon’s knowledge. The FDA designated the Attune knee replacement recall a Class II recall, which indicates that a medical device may cause temporary or medically reversible health problems.
March 2016: DePuy submitted a Section 510(k) premarket notice of intent to market the “ATTUNE® Revision Knee System., which included a new stem, with added length and a keel for additional stability and recessed cement pockets intended to promote cement fixation.
March 2017 DePuy Synthes, at the American Academy of Orthopaedic Surgeons (“AAOS”) announced the launch of the first Attune Knee revision system, which included the Attune Revision Fixed Bearing Tibial Base and a 14 x 50 mm Cemented Stem.
January 2017: A study in the Journal of Arthroplasty suggests that knee replacements may be associated with a high rate of baseplate loosening and failures (such as the Attune knee) due to thicker cobalt-chromium tibial trays that increase the risk of bone loss.
June 2017: The FDA’s MAUDE database included approximately 1, 400 reports of failures. Approximately 633 of these reports resulted in revision surgeries.
September 2017: The first Attune Knee lawsuit LINK pg 2 was filed against DePuy, claiming that a defect in the Attune Knee System caused significant failure of the fixed bearing tibial baseplate in the DePuy Attune cemented knee. Similar failures in the device have resulted in substantial injury, which required patients to undergo revision surgeries.