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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Event Description
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It was reported that 16 years post implantation, the patient was exposed to high chromium and cobalt levels.There is no additional information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports 0001822565-2024-00610 and 0001822565-2024-00611.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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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 evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.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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Event Description
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There is no update to the prior event description provided.
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Search Alerts/Recalls
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