(b)(4).Complaint sample was evaluated and the reported event was not confirmed.The parts passed inspection of the outer profile with the exception of some deformed areas where the liner is damaged.This damage likely occurred during the procedure.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under 4.2.1 and potential harms include poor joint mechanics, significant surgical delay, serious surgical delay, and user dissatisfaction.(b)(4).
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