The company initially recalled its Persona Trabecular Metal tibial implants in February last year due to incidents of radiolucent lines and loosening “higher than Zimmer’s expectation and experience.” Zimmer Biomet said that further investigation indicated that instruments used to prepare for and to perform the implant could be related to the previous recall.
A total of 19 different instrument reference numbers were indicated in the recall, with reference numbers for 8 different modular brackets referenced in each set, according to an urgent field safety notice from the company
The company said that affected sets may cause an implant to not have appropriate initial fixation and cause patient pain, and on the 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.
Zimmer Biomet instructed customers with the devices 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.
In May, the FDA warned Zimmer about a series of quality system violations the federal safety watchdog flagged during January inspections of a plant in Montreal.
The plant makes the iAssist and Zimmer PSI knee systems, the Zimmer PSI shoulder and the Navitrack software system, according to a warning letter dated May 27 and released June 30. The FDA said the inspections, from January 25 through January 28, turned up 9 quality system violations that were issued in a Form 483 notice. Zimmer Biomet responded in February and March, but the March 31 letter missed the 15-business-day deadline and was not reviewed (the agency said it would take a look at it when it reviews the company’s response to the warning letter).
The agency said the initial response dated Feb. 19 failed to address several of the problems, including a lack of procedures for implementing corrective and preventive actions; ensuring equipment calibration, inspection maintenance; receiving and tracking medical device reports; failing to file correction or removal within 10 business days; and failing to record the reason for not reporting corrections or removals.
Zimmer Biomet also lacked procedures for the receipt and evaluation of complaints and failing to ensure that materials and supplies conform to requirements, the FDA said. The company also failed to maintain device master records and lacked procedures for quality audits, according to the warning letter.