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Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problems
Pain (1994); Tissue Damage (2104)
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Event Date 10/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 157454, m2a-magnum mod hd sz 54mm, lot: 592260, part: us157860, m2a-magnum pf cup 60odx54id, lot: 086490, part: x11-180317, bi-metric/x por nc lat 17x165, lot: 219470.Multiple mdr reports were filed for this event, please see associated reports: head: 0001825034-2019-04521, cup: 0001825034-2019-04528, stem: 0001825034-2019-04527.
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Event Description
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T was reported that the patient underwent a primary right tha and subsequently experienced pain and a pre-revision work up revealed osteolysis.During the revision surgery, the surgeon reported debris, altr, along with osetolysis.While attempting to remove head/taper from stem, it was reported as cold-welded to stem, and required trochanter oseteotomy to remove stem.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting pain, osteolysis and large volume of mixed fluid with debris.Cup was removed and large osteolytic areas filled with cancellous bone chips was noted.Upon attempting to remove the head taper from the stem, it was found to be cold-welded requiring a trochanteric osteotomy in order to remove the stem.Dhr was reviewed and no discrepancies were found.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 additional event information to report at this time.
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Search Alerts/Recalls
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