(b)(4).Medical product: unknown tibial tray, cat#: unknown lot#: unknown.Unknown bearing, cat#: unknown lot#: unknown.Unknown patella, cat#: unknown lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-07659, 0001822565-2017-07661.Remains implanted.
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further actions are required.Per the package insert of the femoral component, metal sensitivity is listed as a known potential adverse effect; however.A definitive root cause cannot be determined with the information provided.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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