It was reported by the pmi group that a patient underwent a right shoulder arthroplasty on an unknown date between two (2) to three (3) years ago.Subsequently, the patient was revised on an unknown date approximately two (2) years ago due to fractured screws.During the revision, the patient was converted to a hemi-arthroplasty while waiting for a pmi device to be made due to the patient also having a rotator cuff deficiency.Attempts have been made and no further information has been provided.
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00514; 0001825034-2024-00515.D10: item# unk screw; lot# unknown item# unk screw; lot# unknown g2: foreign - event occurred in the uk no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.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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