(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02603, 0001825034-2022-02604, 0001825034-2022-02605, 0001825034-2022-02607.Medical products: item#: unknown, unknown glenoid baseplate; lot#: unknown.Item#: unknown, unknown humeral stem; lot#: unknown.Item#: unknown, unknown humeral tray; lot#: unknown.Item#: unknown, unknown glenosphere; lot#: unknown.Visual examination of the provided photo shows the explanted baseplate attached to the baseplate extractor.However, as the devices were not returned, further analysis could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.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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