Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Unstable (1667)
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Patient Problems
Local Reaction (2035); Metal Related Pathology (4530)
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Event Date 03/23/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure approximately thirteen (13) years post implantation due to instability and suspected trunnionosis due to an existing metal head on a metal stem neck trunnion.Explant of head revealed black debris inside head and around the rim, evidence to trunnionosis.Surgeon noted that the joint capsule was unusually worn away, most likely due to the metal issue.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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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2022-01062.
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Manufacturer Narrative
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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 (b)(4).
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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 (b)(4).
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Search Alerts/Recalls
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