It was reported the patient underwent an initial right total hip arthroplasty.The patient alleges that he experienced pain, loss of balance, dizziness and difficulty in walking and upset stomach due to the deterioration and failure of implant.Patient also alleges elevated ion levels.No revision has been reported at this time.No additional information.
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(b)(4).Concomitant medical products: ref (b)(4) lot 705240 ringloc shell 54mm, ref (b)(4) lot 403680 arcom liner, ref (b)(4) lot 596070 mallory stem size 9, ref (b)(4).Lot 175850 screw 6.5x35mm.Foreign: country: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03487, 0001825034-2021-03488, 0001825034-2021-03489, 0001825034-2021-03491.
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This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues legal summons line 15-16 patient alleges pain, loss of balance, elevated serum cobalt and chromium levels.Device history record (dhr) was reviewed and no discrepancies were found.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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