Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Fall (1848); Failure of Implant (1924)
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Event Date 03/15/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent an initial knee arthroplasty.Subsequently, the patient fell and that resulted in a revision due to loosening approximately 4.5 years later.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Concomitant products: 621201200 - porous coated stemmed tibial baseplate right size 0 - 63638324; 00542802013 - articular surface ultracongruent 'size 00 0 right 13 mm height' -62327226.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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: 0001822565-2022-00896.
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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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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.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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