(b)(4).Concomitant medical product(s): 00801803202 femoral head 12/14 neck 60676199; 00620204822 shell 60577576; 00771100700 stem 60683864; 00625006525 bone screw 60696741/ multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00092/ reported event was confirmed by review of medical records.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.Operative notes confirmed the patient was being revised for right hip dislocation.The patient had an extensive amount of scar tissue surrounding the neck and it was difficult to externally rotate the hip without getting significantly impinged.Upon dislocating the hip, there was soft tissue entrapping anteriorly.Physician noted that he felt the patient was starting to lever forward.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.
|