(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02707 and 0001825034-2022-02705.Medical products: item#: 113921, bio-mod 44x17mm hd 4mm offset; lot#: 286920.Item#: pt-113950, pt hybrid glen post regenerex; lot#: 497560.Item#: 110027734, comp vrs implt w mi tpr adptr; lot#: 936040.Item#: 110031378, versa-dial taper adaptor 25mm; lot#: 936090.Item#: 115396, comp rvs cntrl 6.5x30mm st/rst; lot#: 989070.Item#: 180554, comp lk scr 3.5hex 4.75x35 st, lot#: 037790.Item#: 180555, comp lk scr 3.5hex 4.75x40 st, lot#: 100270.Item#: 180554, comp lk scr 3.5hex 4.75x35 st, lot#: 987960.Item#: 110030776, 40mm versa-dial glen std, lot#: 65386046.Item#: 110031399, hmrl tray std std, lot#: 65337908.Item#: 110031427, hmrl bearing 40 mm std vite, lot#: 64980844.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital discarded the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02707-1; 0001825034-2022-02705-1.Visual examination of the provided pictures identified a glenoid base with no lot numbers identifiable.The bottom appears to have fractured.The articulating surface shows wear including a worn area through the surface, and wear along the edges.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following assessment of imaging: a right shoulder arthroplasty is present.There is marked superior position of the humeral implant in relation to the glenoid implant consistent with a severe rotator cuff tear.Lucency along the glenoid implant fixation is consistent with implant loosening.There is no evidence of humeral implant loosening.The glenoid appears loose as noted, radiolucency is present.There is malalignment with superior position of the humeral implant in relation to the glenoid.Bone quality is osteopenic.The loosening and rotator cuff tear with migration would lead to revision to a reverse type system.A definitive root cause cannot 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.
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