DePuy Knee Replacement Recalls
Over the past several years, DePuy Orthopaedics knee implant recalls were issued for various reasons. In the late 1990s, DePuy withdrew the Hylamer Polyethylene Bearing Surface of its knee and other joint replacement systems, created to minimize wear in its hip, shoulder, knee and elbow components.
In 2001, the British Government’s Medical Devices Agency issued a recall of the knee implant Hylamer liners that had been sterilized with gamma radiation in air. The recall was ordered after a study showed that patients were exhibiting an extremely high failure rate.
A 67.6-percent failure rate within five years was 13 times the expected rate of failure for the device. It was suspected that the gamma air radiation increased the risk of oxidation of the polyethylene components that were used to connect the knee prosthesis to the tibia, making that part of the implant brittle and prone to breaking down. Because of this risk, DePuy and other manufacturers began replacing gamma irradiation with ethylene oxide, or gas plasma, to sterilize components.
Recall of LCS Knee Implant-Meniscal Insert
In 2008, DePuy issued a recall on its LCS Knee Implant-Meniscal bearing insert. The reason for the recall was that the product had been mislabeled – 10mm inserts were identified as 12.5mm inserts and labeled as such.
Recall of LCS Duofix Femoral Component
In 2009, DePuy issued an international recall of its LCS Duofix Femoral Component. This recall occurred outside the United States, as the component had not been approved for domestic sale by the federal Food and Drug Administration. In its recall notice, the company said that it had identified “increased revision rates” – a higher than average number of surgical repairs associated with the component, primarily in Australia.
Alumina Particles Detected
The company also determined that Alumina particles detected in the joint space was a factor that may have been responsible for symptoms of pain and swelling. Alumina is a bio-compatible material used to roughen the internal surface of the implant in the Duofix manufacturing process.
Studies from Great Britain showed an unusually high failure rate for the DePuy Preservation Knee Replacement implants. Data from the England and Wales National Joint Registry (NJR) revealed that the mobile bearing variant of the Preservation unicompartmental knee system had a higher than expected early revision rate compared to other unicompartmental knee systems used in those countries. Of 264 DePuy Preservation unicompartmental mobile bearing knee implants recorded on the NJR database between 2003 and 2008, 34 (12.9 percent) had been “revised” as of July 2009.
The DePuy Preservation Knee Replacement implants caused a range of problems for patients, including: loosening, pain, wear of the polyethylene component and early periprosthetic fracture (a fracture around an implant). The exact cause for the high revision rate was not known but was likely due to several factors.
In light of this information and after continuing analysis by the manufacturer, DePuy ceased actively promoting the mobile bearing variant of this knee system in the UK and confirmed to the country’s Medicines and Healthcare Products Regulatory Agency that it would be discontinued throughout Europe from August 2009 onward.
