Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 07/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 11-103203 ¿ taperloc stem ¿ 042650, us157850 ¿ m2a magnum cup ¿ 0644600, 157444 ¿ m2a magnum head - 742780.Customer has indicated that the product will not be returned for the 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 - 2019 - 03763.
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Event Description
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It was reported that patient underwent a left hip revision approximately 12 years post implantation.During the surgery, the taper adapter was found to be cold-welded to the stem.The appropriate extraction instrument was not available so the surgeon attempted to remove the taper without and ended up dislodging the stem.The trochanter ended up fracturing as a result.The fracture was fixed with a trochanteric plate and 5 cables.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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Reported event was confirmed by review of medical records noting left hip metallosis, cold welded head and neck sleeve, intraoperative fracture of the greater trochanter.The fracture was fixed with plate and 5 cables.Dhr was reviewed and no discrepancies 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.
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Event Description
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No additional event information at this time.
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Search Alerts/Recalls
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