(b)(4).Concomitant devices - avl hinge lock ring catalog #: rd119120 lot #: 336560, avl rotating hinge knee axle catalog #: rd119125 lot #: 406770, lombardi hinge knee femoral component 60mm right with porous coat catalog #: cp111797 lot #: 606610, avl rotating hinged knee 60mm non-modular tibial base plate catalog #: cp111798 lot #: 569680, finn rotating hinged knee modular bond stem size 11.5mm x 152mm catalog #: cp111799 lot #: 569510, orthopedic salvage system locking pin catalog #: 150478 lot #: 223150, lombardi hinge femoral bushing catalog #: rd119021 lot #: 859300, avl rotating hinge knee tibial bushing set catalog #: rd119111 lot #: 411130, avl rotating hinge bearing 60mm x 16mm catalog #: rd119072 lot #: 395040, avl rotating hinged knee 5 degree hyperflexion bearing set 60mm x 12mm & 14mm & 16mm catalog #: cp111836 lot #: 569470.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-00482, 0001825034-2023-00483.
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It was reported that the patient is being considered for a right knee arthroplasty revision approximately twenty years post-operatively to address component failure; however, the extent and nature of the failure is unknown.Attempts have been made, however, no additional information is available.
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