It was reported the patient underwent left total hip arthroplasty.Subsequently, the patient underwent a revision approximately 2 years later due to aseptic loosening of the femoral stem, pain and difficulty ambulating.During the revision, a lack of in-growth on the femoral stem was noted.The stem, head, and liner were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
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(b)(4).Concomitant medical products: ref (b)(4), lot 6601603, g7 shell; ref (b)(4), lot 64495274, screw; ref (b)(4), lot 64563153, screw; ref (b)(4), lot 948540, dm liner; ref (b)(4), lot 560940, dm bearing; ref (b)(4), lot 2983045, biolox head; ref (b)(4), lot 6551317, taperloc stem.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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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.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues contralateral hip performed, increase in pain with ambulation, x-ray shows radiolucency around stem, no ingrowth was noted.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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