Model Number N/A |
Device Problem
Malposition of Device (2616)
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Patient Problem
Unequal Limb Length (4534)
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Event Date 08/19/2023 |
Event Type
Injury
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Event Description
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It was reported that approximately 7 years post implantation the patient had gluteal issues and a malrotated arcos stem, with a leg length discrepancy.The length of the discrepancy was unspecified.The surgical technique was followed, and there were no signs of loosening or subsidence.The old stem was removed, and a new arcos stem was inserted.There was no surgical delay and no contributing conditions related to the event.Though requested, no additional information was received.
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Manufacturer Narrative
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(b)(4).D6a: implant date: the device was implanted sometime (b)(6) 2016.G2: foreign: country: australia.Multiple mdr reports were filed for this event, please see associated report: 0001825034 -2023 -02036.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.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint could not be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause could not 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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