Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: x11-170310 ¿ integral stem ¿ 275840.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 - 2019 - 01422.
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Event Description
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It was reported that patient underwent a right hip revision approximately 11 years post implantation.During the surgery, the metal head was noted to be cold welded to the stem.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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Reported event was confirmed by review of medical records.Revision op notes demonstrated that when the hip was opened, the metal head was found cold-welded to the trunnion, and there was significant wear identified to the trunnion and inside the femoral head.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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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Search Alerts/Recalls
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