Model Number N/A |
Device Problem
Naturally Worn (2988)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 04/27/2022 |
Event Type
Injury
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Event Description
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It was reported the patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 23 years post implantation due to metal on metal wear and metallosis found on both acetabular component and femoral stem.Additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown mallory acetabular cup 46mm; unknown 28mm -6neck type 1 taper cobalt chrome head; unknown taperloc stem.Report source: foreign country (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01000, 0001825034-2022-01002 and 0001825034-2022-01003.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 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.
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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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Search Alerts/Recalls
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