Recall of the Zimmer Biomet Regenerex 3 Peg Series A Patella
Zimmer Biomet designed, developed and marketed the Vanguard Complete Knee Replacement System for the purpose of reconstructing diseased human knee joints resulting from conditions such as osteoarthritis, rheumatoid arthritis and traumatic arthritis. The Regenerex 3 Peg, Series A Patella was designed, developed and marketed by Zimmer Biomet as a component available for the use of surgeons with the Vanguard Complete Knee Replacement System. Modern knee replacements are generally expected to last 15 or 20 years or more.
Following commencement of sales of the Regenerex Patella, Zimmer Biomet received numerous reports of failures of the Regenerex Patella through their sales representatives and by way of medical device reports to the FDA Manufacturers and Users Device Experience (“MAUDE”) reporting system. These reports were that the pegs on the Regenerex Patella would fracture and shear off during normal usage, causing the pieces of the fractured Regenerex Patella to become disassociated and migrate through the knee joint causing pain and requiring surgical intervention.
In early 2017, Zimmer Biomet initiated an Urgent Medical Device Recall, FDA Recall Number Z-2068-2017, of all Regenerex Series A Patellas. As disclosed on the FDA website, the reason for the recall was “pegs shearing post-operatively”.
Had Zimmer Biomet conducted clinical trials of the Regenerex 3 Peg Series A Patella before it was first released on the market in 2009, they would have discovered at that time what they ultimately learned later – that the Regenerex 3 Peg Series A Patella was defective and unreasonably dangerous in that its pegs could shear off under normal conditions of usage, resulting in: (i) disintegration of the titanium Regenerex Porous Construct coating on the patella and release of copious amounts of metal debris into the knee joint and (ii) the need for additional, dangerous surgery to remove the fractured patella and broken pegs, replace the patella, remove the metal debris and to replace other components of the knee replacement damaged by the metal debris or trapping the metal debris.
The lawyers at Wagner Reese are currently investigating and litigating cases in involving the defective Regenerex 3 Peg Series A Patella with multiple cases currently filed. The allegations in the pending complaints make it clear that this is just another example of a company putting profits above safety. Zimmer Biomet failed to exercise reasonable care in the designing, researching, manufacturing, marketing, supplying, promoting, sale, testing, quality assurance, quality control, and/or distribution of the Regenerex Patella and the Vanguard Complete Knee System. Zimmer Biomet knew or should have known that those individuals that had the device surgically implanted were at risk of unreasonable, dangerous injuries.
If you or a loved one had a defective Zimmer Biomet Regenerex 3 Peg Series A Patella implanted and experienced an injury from the device, please call Jeff Gibson of the Wagner Reese law firm for a free consultation.