It was reported that during an initial left knee arthroplasty, the surgeon opened the femoral packaging and found the femoral inside to be for a right knee, and a different size than was listed on the labelling.No adverse events have been reported as a result of the malfunction.
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This follow-up report is being submitted to relay additional information.Updated: b4, d9, g3, g6, h2, h3, h6, and h10.Proposed component code: mechanical g4 - femur complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified part#183104 was found in the package of part#183122.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.The root cause of the reported issue is attributed to a manufacturing issue.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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