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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 09/01/2022 |
Event Type
Injury
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Event Description
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It was reported the patient underwent initial left total hip arthroplasty.Subsequently the patient was revised approximately 3 (three) weeks later due to periprosthetic fracture.The head and stem were exchanged with cerclage cables applied to femur without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: ref 650-0661 lot 6095602 head, ref 6202-52-22 lot 64148136 shell, ref 6305-50-36 lot 64893966 polyethylene liner, ref 6250-65-25 lot j7249809, j7263674 bone screw.The device will not be returned for analysis, as the device was discarded; 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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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.H6 suggested code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues periprosthetic femur fracture, previous incision utilized, cables applied, femoral stem removed easily, new stem placed, no complications.Mmi impressions: periprosthetic fracture involving the proximal femoral diaphysis medial cortex.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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