Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 04/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: unknown oxford femoral component; item# unknown; lot# unknown.Oxf anat brg rt sm size 4 pma; item#159569; lot#1282040.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : item number and lot number unknown.
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Event Description
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It was reported that the patient underwent total knee arthroplasty revision due to tibia collapse.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 and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of manufacturing records cannot be performed without product identification.The 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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