(b)(4).Mfr site- foreign: switzerland.Associated products: item number:01.04223.236, item name: anatomical shoulder¿ reverse, glenoid head, 36, lot number: 2336445.Item number: unknown, item name: unknown anatomical shoulder reverse humeral insert, lot number: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00492.As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The devices are used for treatment.Four intraoperative images were received.The first image shows the as reverse cup and liner in-vivo.The inferior portion/rim of the liner is notably worn and exposing the rim of the cup.The second picture received shows the recently explanted cup and liner in the surgical room.The exposed inferior rim of the cup is worn.The third image shows the exposed humeral stem interface, where the cup was inserted.Some sign of metallosis is evident.The glenosphere appears slightly in this image.The final image shows the exposed glenoid of the patient after all components were removed.No surgical reports or x-rays were received.The implant angle of the as reverse cup in relation to the glenosphere is unknown.Of note is the long implantation time of approximately 15 years.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|