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Zimmer Persona Knee Subjected to Yet another Recall in Early 2016

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Washington, DCMost are familiar by now with the Zimmer Persona Recall of 2015, and in particular the Persona Trabecular Metal Plate that could loosen and cause pain and the ultimate failure of the knee. The voluntary recall was initiated by Zimmer in February of last year, with the US Food and Drug Administration (FDA) endorsing the recall the following month, in March.

Many a Zimmer Persona lawsuit has stemmed from that recall.

Well now, there’s another one.

Zimmer Biomet, Inc. - the manufacturer of the Zimmer Persona Knee system - quietly recalled various components used to facilitate the installation of joint replacement implants. The recall occurred this past spring, with the FDA issuing an enforcement report in mid-June.

According to a government release (6/18/16) the FDA issued an enforcement report for the “Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

“Zimmer Inc. is initiating a recall of specific Persona ‘Trabecular Metal’ Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants,” the release stated.

The enforcement report identified a product quantity of 10,256 units with the recalled components distributed across much of the continental US as well as Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, France and Luxembourg, the Netherlands, South Africa, Spain, Sweden, Switzerland, and the United Arab Emirates.

The Zimmer Persona Recall was initiated on May 11 of this year.

Zimmer, based in Warsaw, Indiana ran into trouble in 2015 with its Zimmer Persona Knee system. The Trabecular Metal Plate was shown to be failing in a high number of cases. Patients, having been assured that with normal wear and tear an artificial knee would be expected to last upwards of fifteen years, were now finding their knee implants to be failing after a few short years and in some cases, as early as 18 months following initial surgery.

It should be noted that the Zimmer Persona Knee system - like devices made by a host of other manufacturers - was able to capitalize on a loophole in the FDA approval guidelines which holds that a proposed device similar to devices already on the market and performing well, could bypass the stringent clinical trial process and proceed to the market sooner. The 510(k) Clearance was designed to bring promising products - with their inherent benefits - to patients and consumers years in advance of what it would ordinarily take to appear by being hung up in the clinical trial process.

The reality, for many manufacturers and their patients, has not mirrored the theory behind the 510(k) Clearance. New materials introduced into the manufacturing process, and not properly tested in real-world contextual situations over the long term, have proven to be an Achilles’ heel to many a manufacturer and a bane to patients forced to go under the knife yet again for a revision procedure not far removed from successfully healing, from the first.

Many a patient dealing with Zimmer Persona Knee pain have filed personal liability and injury lawsuits alleging that Zimmer manufactured a defective product and unnecessarily subjected the plaintiff to needless pain and suffering - not to mention the rigors of having to go through a second surgical procedure. Revisions can be more complex than the original surgery, with the potential for increased complications and the need to take additional time away from a job or career for yet another round of healing, and rehabilitation.

A Zimmer Persona Plate lawsuit is the plaintiff saying, “You can’t put me through this and get away with it.”

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READER COMMENTS

Posted by

on
I have the revision done o 7 11 kept the parts and look at zimmer recall list the number match call Barry Darvin 248 214 xxxx

Posted by

on
i had the personna installed july 19 2016..ive had a tremandeous amount of trouble with the implant like it never was normal..did they put one in that was recalled?

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