(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.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: 0002648920-2020-00085, 0001822565-2020-00619, 0001822565-2020-00622.
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It was reported that patient began experiencing symptoms of metal reaction approximately 7 years post initial hip procedure including repeated falls, weakness, headaches, vision problems, and memory loss.Symptoms have continued to worsen and is additionally experiencing muscle spasms, loss of balance, pain in the hip, mid thigh, groin and back, memory loss, weakness, skin rashes, and ringing in the ears.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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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h6 reported event was unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed, as the lot number for the device is unknown.The root cause is unable to 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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