Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - medical devices: oxf twin-peg cmntd fem sm pm; item# 161468; lot# 857450.Oxf anat brg rt sm size 3 pma; item# 159568; lot# 242190.Multiple mdr reports were filed for this event, please see associated report: 3002806535 - 2023 - 00441 and 3002806535 - 2023 - 00447.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.
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Event Description
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It was reported that patient underwent a uni knee arthroplasty and approximately 5 years later a revision surgery was performed due to the loosening of the implant.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 confirmed no abnormalities or deviations that could be related to the reported event.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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Search Alerts/Recalls
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