(b)(4).Item# 00434903811; lot# 61955510 item# 00434903611; lot# 61949538 item# 00434901213; lot# 61855815 item# 01.04223.042; lot# 2611617 customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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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