Model Number N/A |
Device Problem
Malposition of Device (2616)
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Patient Problems
Ossification (1428); Osteolysis (2377)
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Event Date 07/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown avenir complete stem, unknown head, unknown liner.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03316.
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Event Description
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It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised due to unknown reason.X-ray review shows acetabular implant is abnormally vertical in position.There is heterotopic ossification laterally and a metallic density overlying the acetabulum and there is suspected proximal femoral osteolysis at the proximal femur.Attempts have been made and additional information on the reported event is unavailable.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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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.Review of radiographs provided show abnormal orientation of the cup.Loosening/osteolysis were suspected, but not confirmed.Device history record (dhr) 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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