(b)(4).Concomitant medical products: unknown stem, unknown cup, unknown head.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.Device remains implanted in the patient.
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It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient experienced liner wear.However, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable.
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