(b)(4).Concomitant medical products: 51-106120 ¿ taperloc stem ¿ 3330377.650-1162 ¿ delta ceramic head ¿ 2016022279.00620205420 ¿ shell ¿ 62616448.Report source canada.Product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 02778.
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It was reported that patient is experiencing pain, loss of balance, dizziness, difficulty walking and upset stomach.Patient also alleges elevated serum chromium and cobalt levels, metallosis, tissue dehiscence, tissue necrosis, bone necrosis, hypertrophic scarring, antalgia, lumbar strain, chronic fatigue and severe distress related to pain and suffering after an unknown amount of time post total hip arthroplasty.No revision surgery has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.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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