Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 07/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2 ¿ foreign ¿ germany.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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It was reported that ceramic inlay fractured about sixteen (16) years after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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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.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.H3 other text: device location is unknown.
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Search Alerts/Recalls
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