Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 06/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 42502606402 - femur cemented cruciate retaining (cr) standard right size 8 - 64824134.42522100813 - articular surface medial congruent (mc) right 13 mm height use with tibia.Sizes e-f/cr femur sizes 8-11 - 64411366.42540200035 - all-poly patella cemented 35 mm diameter - 64833139.Report source: foreign country: (b)(6).The 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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It was reported that the patient underwent a right total knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately 1 month later due to tibial subsidence.Attempts have been made and no further information has been provided.
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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 no photographs were provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.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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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.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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