(b)(4).Concomitant medical products: catalog number:650-0662 lot number: 3256336 brand name: delta ceramic femoral head, catalog number:131350bm lot number:3106556 brand name: exceed ringloc shell, catalog number:ep-083650 lot number:2430446 brand name: ringloc liner.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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 experienced left hip bursitis and limited range of motion approximately 2 years post implantation.However, no revision has been reported to date, patient remains in clinical study and implanted.No further reports of bursitis or rom issues in following visits.Additional information on the reported event is unavailable.
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