It was reported that a patient had a complex revision history of a right reverse total shoulder arthroplasty, including multiple periprosthetic fracture repairs and mrsa infection in the joint.The patient underwent an additional revision due to unknown reasons.Three weeks later, the patient underwent an irrigation and debridement with no reported product exchange.No medical records or additional information has been provided to further detail the event.
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(b)(4).Multiple mdr reports were filed for this event.Please see the associated reports: 0001825034-2024-00783, 0001825034-2024-00784, 0001825034-2024-00785, 0001825034-2024-00787, 0001825034-2024-00788, 0001825034-2024-00789, 0001825034-2024-00790.D10: concomitant medical products, part number (lot number): 211215 (179160), 211226 (966890), 211236 (829710), 115340 (738490), 118000 (139820), xl-115368 (469610), ti-115323 (620400).E1: full establishment name: (b)(6).The customer has not indicated whether the product will be zimmer biomet for investigation, and the product 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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