Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Cognitive Changes (2551); Metal Related Pathology (4530)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).D9: implant date 2011.D10: cat# unknown lot# unknown - unknown stem.Cat# unknown lot# unknown - unknown head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00135; 0001822565-2024-00136.Product 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 the patient underwent a hip arthroplasty approximately twelve years ago.Subsequently, the patient is being considered for a revision on an unknown date for cobalt in the bloodstream causing cognitive decline.Though requested, no additional information was available.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records and compatibility checks, and neither were provided.The reported issue cannot be confirmed; however, it was determined that the cup was likely unrelated to the reported issue.A definitive root cause cannot 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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