Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date of event: the event occurred sometime between 2011-03-28 and 2023-02-28.Unknown taperloc short.Foreign: country: poland.Customer has indicated that the 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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2023-00493.Device remains implanted.
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Event Description
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It was reported that during the inspection, the x-ray showed that right hip implanted recap acetabulum, magnum head, and taperloc short.The implants are currently implanted.The patient had symptoms of pain.No revision has been reported to date.There were no contributing conditions related to the event.No additional information.
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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/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues, and the impressions were: anatomic alignment of the right hip arthroplasty.Part and lot identification are necessary for review of device history records and compatibility checks; neither were 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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No further event information is available at the time of this report.
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Search Alerts/Recalls
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