(b)(4).Complaint sample was evaluated and the reported event was confirmed.Product evaluation stated, "the part passed inspection of the outer profile with the exception of some deformed areas where the liners are damaged.This damage likely occurred during the procedure." dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to human error.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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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