Model Number N/A |
Device Problem
Degraded (1153)
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Patient Problem
Local Reaction (2035)
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Event Date 09/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 14-103206 taperloc stem 12.5mm 186560.11-173663 m2a 38mm mod hd 158870.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product was not returned by the patient.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 - 2021 - 02850.
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Event Description
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It was reported a patient underwent an initial hip arthroplasty.The patient underwent a revision fifteen years post implant due to adverse tissue reaction from metal debris.Attempts have been made and no further information has been provided.
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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 unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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