The root cause for the patient developing metalosis was unable to be definitively determined.The sales representative did not give information on the condition of the explanted components.The components were discarded, and no analysis will be conducted.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
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A (b)(6) male patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) to the patient having metalosis.During the surgery, the surgeon removed all of the implants that contained poly components and replaced them with new implants.The resurfacing femur and tibial baseplate, which are the interfacing components with the explanted implants, were not explanted.
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