(b)(4).
Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02562, 0001822565-2020-02561, 0001822565-2020-02875.
Item# 00249000424; lot# 61793873, item# 00249000432; lot# 63206145, item# 00249000430; lot# 63210804, product has been received by zimmer biomet and the investigation is in process.
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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