FDA Issues Class II Recall On Zimmer Persona Knee Prosthesis

Safety Notice From US Authority


Specialist product liability lawyers have welcomed the US Food and Drug Administration’s (FDA’s) decision to issue a notice for a Class II Recall for all lots and sizes of the Zimmer Persona Trabecular Metal Tibial Plate knee implant.

Following the recall of the Persona in February 2015, Zimmer has now issued an urgent recall notice to all hospitals, doctors and surgeons, announcing that all affected products must be located and quarantined immediately.

The FDA's notice states that the recall has been initiated following 'an increase in complaints of radiolucent lines and loosening'.

Initial reports suggest that in excess of 10,000 persona knees currently in circulation in America will be withdrawn. The prosthesis is also widely used in Europe where recall numbers have not yet been identified, but it is likely that a significant number of European products will also be quarantined.

Radiolucent lines are usually an early sign of loosening, which in many cases will lead to a need for revision. Patients who have recently received a Zimmer Persona prosthesis may therefore be at greater risk of the need for early revision and should seek urgent medical advice if they are suffering from symptoms of pain or altered mobility.

Matthew Newbould, a specialist lawyer in product liability at Irwin Mitchell, is currently representing Claimants injured by the Zimmer Durom hips, De Puy ASR hips, De Puy Pinnacle Hips, and Smith and Nephew Journey knees.

Expert Opinion
The recall of the Persona knee system is the latest in a long line of recorded problems with Zimmer artificial joints.

"Zimmer is currently defending multi-district litigation brought by over 1,000 knee patients in the District Court of Illinois arising from the alleged early failure of Zimmer Nexgen high flex knee prostheses, as well as group litigation in the US and UK arising from the early failure of the Zimmer Durom and Metasul hip prosthesis.

"Zimmer knee products have been recalled by the United States Food and Drug Administration (FDA) for a variety of reasons over the last few years, including 'non-conforming internal geometry', out of specification screw threads, and multiple complaints of excessive loosening.

"The Persona prosthesis was approved under the FDA's fast tracked 510k procedure as 'substantially similar' to the standard Zimmer NexGen prosthesis, which generally performs well in National joint registry databases. According to Zimmer, the Persona should improve upon the NexGen design by providing a more personalised, and superior, anatomical fit.

"The FDA has not yet specified the extent of the problem with loosening with the Zimmer Persona and it is unlikely that the true failure rate will become apparent in the very near future, because the product was only introduced in 2012. For the moment, Zimmer Persona patients face an anxious wait until the extent of the problem is clarified by Zimmer and the FDA."
Matthew Newbould, Solicitor

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