Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, as the implants were kept by the surgeon/facility based on their policy; 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 the patient underwent hip revision due to a fractured arcos prosthesis.The stem was removed and replaced.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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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: transversely oriented fracture of the hardware and overlying bone noted in the subtrochanteric diaphysis region of the left femur.The proximal femur is displaced laterally by greater than 1 shaft width with respect to the femoral diaphysis.Remainder of the hardware appears intact.No contributing factors are detected with respect to the femoral hardware to account for this fracture.Part and lot identification are necessary for review of device history records, neither were provided.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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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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