Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: us157856 ¿ m2a magnum cup ¿ 342680; 157450 ¿ m2a magnum head ¿ 409320; 139252 ¿ m2a magnum taper ¿ 908670.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04158, 0001825034 - 2020 - 04160, 0001825034 - 2020 - 04161.
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Event Description
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It was reported that patient has been indicated for a right hip revision after approximately 11 years post implantation due to unknown reasons.No revision surgery has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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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 provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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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