On the literature review " initial safety profile assessment of the navio robotic-assisted total knee arthroplasty ", it was reported that, after undergoing a navio-assisted ra-tka procedure, one (1) patient experienced deep infection.It is unknown how this adverse event was treated.No further information is available.
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H3, h6: the navio surgical system us, part number npfs02000, 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 without the requested medical documentation, definitive clinical factors which could have contributed to the reported event could not be concluded.A complaint history review for similar reported/confirmed complaints has identified prior events.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.This failure mode and associated risk could be a potential factor for the reported event and the documented risk level is still within the product risk profile.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with instruments not sterile after proper cleaning and sterilization.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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