Zimmer Biomet Holdings, Inc. is recalling some Persona Trabecular metal tibial plate instruments and modular brackets.
Zimmer Biomet Recalls Some Persona Instruments and Brackets
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In February 2015, the company initiated a recall of Persona Trabecular Metal Tibial Implants due to incidents of radiolucent lines and loosening higher than Zimmer’s expectations and experience based on Zimmer’s similar devices. At the time, the company said further investigation into the reported issue indicated that the instrumentation used to prepare the bone for the Persona Trabecular Metal Tibial Plate Implant, and to implant the Persona Trabecular Metal Tibial Plate could be related to the reported issue.
Urgent Field Notice
On May 25, 2016, the company issued an “Urgent Field Safety Notice-Part Number Specific” and initiated the instrument and bracket recall.
A total of 19 different instrument reference numbers were in the recall, with reference numbers for 8 different modular brackets referenced in each set, according to the field safety notice.
The company said that affected sets may cause an implant to not have appropriate initial fixation and cause patient pain, and long-term could lead to implants never achieving biological fixation, which could necessitate revision surgery. However, the risks were noted as “worst case” scenarios, and that the most probable outcome would be no adverse events.
Customers with the devices were instructed to quarantine affected products and contact the company to remove the product. The company also said it will report the voluntary recall to local authorities.
After the initial February 2015 recall, lawsuits were filed by patients. According to various attorneys engaged in those lawsuits, some patients reported loosening of the plates. According to a June article on LawyersandSettlements.com, this, in part, appears to be exacerbated by a lack of bone growth into the tibial plate, which would serve to anchor the plate. “For a statistically large number of patients, this bone growth was either insufficient or not happening at all, leading to Zimmer Persona Knee pain and failure of the artificial knee, ” stated the article.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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