Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 06/05/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an initial knee arthroplasty.Approximately 19 years later a revision procedure was performed due to articular surface wear and fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).G2 - foreign: japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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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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(b)(4).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.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were not provided.With the available information, 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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