Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/10/2024 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a knee arthroplasty, and subsequently a revision surgery was performed due to the failure of the tibia component.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).D10 - medical devices: unknown oxford femoral component; item# unknown; lot# unknown.Unknown oxford bearing; item# unknown, lot# unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : product is unknown.
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Manufacturer Narrative
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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.Device is used for treatment.Medical records were not provided.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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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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