(b)(4).Item # 42532007502 lot # 63078128, item # 42521000510 lot # 62846474, item # 42540000032 lot # 63104082.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00454, 0002648920-2019-00455, 0002648920-2019-00479.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary surgical note was provided and found no complication.The office visit notes states that there is a delay in the healing wound.Device history record was reviewed and no discrepancies were found.No product was returned; visual and dimensional evaluations could not be performed.A definitive root cause cannot be determined.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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