It was reported to aesculap ag that a columbus knee system (part # n801z) was implanted during a procedure performed on (b)(6), 2021.According to the complainant, before unpacking the columbus as implant, a coating issue was observed.Reportedly, the cement pockets appeared to be without as coating.The procedure was completed using a replacement device.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference cc (b)(4).
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