Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Information (3190)
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Event Date 05/31/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: us157854 - m2a magnum cup - 376760; 103205 - taperloc femoral stem - 775170; 157448 - m2a magnum head - 491740.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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: 0001825034-2018-09588.
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Event Description
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It was reported patient underwent hip revision approximately 9 years post implantation due to metallosis.During the surgery, the head component was found to be cold welded to the stem resulting in the removal of a well fixed stem.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 received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-00357.
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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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