Cmp (b)(4).
Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00014 delano lag screw item #: 814510105 lot #: ug1111305d delano a/r screw item #: 814501090 lot #: dnccm1 foreign - event occurred in (b)(6).
Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.
Once the investigation has been completed, a follow-up mdr will be submitted.
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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