Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/01/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an initial left knee arthroplasty.Approximately 7 years later, a revision procedure due to bearing fracture was performed.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: switzerland.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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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.A review of the device manufacturing records could not be performed due to missing lot number.With the available information, 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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