(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device will not be released by hospital.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.Concomitant medical products: item# 00620206220 / tm mod cup multi-hole / lot # unknown.Item# unknown / unknown bone screw / lot # unknown/quantity 4.Item# 00631006236/ tm mod liner 36mm/ lot # unknown.Item# unknown/ unknown allo-pro femoral stem/ lot# unknown.Item# unknown/ unknown competitor head/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -02422.0001822565 -2020 -02423.0001822565 -2020 -02427.0001822565 -2020 -02428.0001822565 -2020 -02429.
|
It was reported patient underwent right hip revision surgery 9 years post implantation due to shell loosening and instability.Shell, liner, screws and competitor head were revised.Attempts have been made and additional information on the reported event is unavailable at this time.
|
Medical records were reviewed and revealed that the patient underwent a primary right hip arthroplasty in 1988, and underwent revision of right acetabular cup due to wear in 1995.2nd revision was performed due to pain, loosening, and lack of boney ingrowth of shell.During the revision, new zimmer biomet trilogy cup, liner, and bone screws were implanted.A competitor's head was used as the surgeon did no have other heads available for the 14-16 french trunnion on the allo-pro femoral stem.The cup was implanted at approximately 45 degrees inclination and at 25-30 degrees anteversion.Good stability and range of motion were achieved.No complications occurred.The patient was revised again due to loosening of the cup and instability.The operative notes for the 2020's revision procedure were not provided.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.
|