Cmp- (b)(4).Customer has not indicated whether the product will be returned to zimmer biomet for investigation.Product still remains implanted at this time.Once the investigation has been completed, a follow-up mdr will be submitted.Medical products-comprehensive reverse tray catalog#:115370 lot#:488700; comprehensive primary stem catalog#:113668 lot#:044560; central screw catalog#:115396 lot#:402710; locking screw catalog#:180551 lot#:369350; locking screw catalog#:180553 lot#:651160; non-locking screw catalog#: 180558 lot#:030300; non-locking screw.Catalog#:180557 lot#:030260; comprehensive glenosphere catalog#:115310 lot#:383280; humeral bearing catalog#:ep-115393 lot#:864620; steinmann pin catalog#:405800 lot#:572700; drill catalog#:405883 lot#:797890; bone cement catalog#:402433 lot#:003990; hip kit catalog#:417000 lot#:608885; dia drill catalog#:405889 lot#:958000.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02912, 0001825034-2017-02926, 0001825034-2017-02913, 0001825034-2017-02931, 0001825034-2017-02884, 0001825034-2017-03047, 0001825034-2017-03048, 0001825034-2017-03049, 0001825034-2017-03050, 0001825034-2017-03053, 0001825034-2017-03052, 0001825034-2017-03051, 0001825034-2017-01739.
|
It is reported the patient underwent a reverse shoulder arthroplasty.Subsequently, approximately two (2) years post-operatively, the patient experienced a loud pop in the shoulder and pain.Subsequent radiographs revealed a peri-prosthetic fracture and indications that the humeral tray may be loosening or disconnecting from the humeral stem.No revision procedure has been reported to date.
|
It is reported the patient underwent a reverse shoulder arthroplasty.Subsequently, approximately two (2) years post-operatively, the patient experienced a loud pop in the shoulder and pain.Subsequent radiographs revealed a peri-prosthetic fracture and indications that the humeral tray may be loosening or disconnecting from the humeral stem.Patient was later revised to a custom reverse shoulder transplant.
|