(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00509, 0001825034-2024-00510, 0001825034-2024-00511.D10: item# 010000589; lot# 928910, item# 115395; lot# 988780, item# 180552; lot# 856440, item# 110035372; lot# x12aaf1707, item# 00434901013; lot# 65492269, item# 00435003603; lot# 65243570, item# 00801102016; lot# 65346659.G2: foreign - event occurred in japan.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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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