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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problem
Metal Related Pathology (4530)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).D6a.: implanted date: (b)(6) 2006.D10: cat#: unknown, lot#: unknown, unknown head; cat#: unknown, lot#: unknown,unknown stem.Product remains implanted.And will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported, that approximately 18 years post implantation of a total hip arthroplasty.The patient is scheduled, for a revision surgery to remove and replace the cup.It was reported, that the patient's cobalt and chromium levels are elevated, and the patient has various metallosis issues.A recent mri was reported, to also show significant fluid accumulation around the implant.No additional information available.
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Event Description
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 9613350 winterthur.
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Manufacturer Narrative
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Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-01036, 0001825034-2024-01037.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 9613350 winterthur.
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Search Alerts/Recalls
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