(b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation.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 - 02449 and 0001822565 - 2021 - 02451.
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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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified abnormal alignment of the acetabular cup, presumably from loosening from its originally positioned location, now rotated counter-clockwise, resulting in offsetting of the femoral head/acetabular alignment.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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