It was reported that, after a cori-assisted right tka surgery had been performed on (b)(6) 2022 with a legion cr system, clinical subject experienced lower leg swelling on (b)(6) 2022.The right calf/knee was swollen and superficial wound fluid ooze came from lower leg, this increased with onset of erythema.The patient was admitted and discharged the same day.Infection and dvt were excluded.A conservative treatment was performed to treat this event: clinical subject was encouraged to moisturize lower legs to prevent wound complications and venous eczema.Recovery is ongoing.
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H3, h6: the real intelligence cori, part number rob10024, serial number unk, used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that since it was reported the patient¿s recovery is ongoing, the impact to the patient beyond that which has already been reported cannot be determined.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.As with any surgical procedure, there is risk involved.Potential complications accompanying surgery may occur, including: allergic reaction (anaphylactic and minor), infection, mild to serious physical injury, localized static shock, delay in the operation, surgical site nerve injury, vascular injuries of the lower extremity, soft tissue damage, major bone gouging at the surgical site, bone fracture, immature implant failure, unstable knee joint, limited or restricted knee range of motion, major blunt impact injury, unintended laceration/puncture wound, and osteonecrosis.The risk review could not be completed as no sufficient information was provided that relates the specific failure mode to the device.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with post operative complications.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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