(b)(4).Medical devices: partial femur cemented size 5 right medial catalog#: 42558000502 lot#: 64512726, partial tibial cemented size e right medial catalog#: 42538000502 lot#: 64403090.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
This follow-up report is being submitted to relay additional information.Updated: a1, b3, b4, d7, g4, g7, h2, h3, h6, and h10.Reported event was confirmed by review of medical records.Revision operative notes were provided and it confirms that patient underwent revision due to infection.There was no pus, but there was a fair amount of synovitis and granulation tissue.Revision pre-operative follow up stated that patient had pain, swelling and stiffness.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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.
|