(b)(4).Multiple mdr reports were filed for this event.Please see the associated reports: 0001825034-2021-01549, 0001825034-2021-01551, 0001825034-2021-01552, 0001825034-2024-00891, 0001825034-2021-01553, 0001825034-2021-01554, 0001825034-2021-01555, 0001825034-2024-00893, and 0001825034-2024-00894.D10: associated product information, part number (lot number): 010000589 (913310), 115396 (074240), 180553 (586200), 180553 (586200), 180551 (761260), ti-115313 (580230), 113627 (161460), 115340 (597650), and xl-115363 (276000).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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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It was reported that a patient with a known history of nickel allergy underwent a conversion from a right shoulder hemiarthroplasty to a reverse total shoulder arthroplasty due to rotator cuff deficiency with capsular contracture approximately nine years (9) and three (3) months ago.After implantation, the patient continued to have range of motion concerns, pain, swelling, low fevers, and skin lesions.After a negative infection workup, the patient was found to have an allergy to vanadium.The patient underwent explantation of all components approximately four (4) years and five (5) months later.During the procedure, there were no signs of loosening or infection.An osteotomy was required to remove the well-fixed stem.Cerclage wires were placed to stabilize the osteotomy, but no shoulder implants were inserted.No complications were reported as a result of the surgery.Attempts have been made, and no further information has been provided.
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