It was reported that during case the graph was not representative of what the outcome was.Doctor discussed the placement of the implants in depth before moving past the gap balancing screen.Based on the looseness felt in the joint itself when planning the placement, essentially ignoring the gap graph.After placing the implants, as planned, determined there was about 1-3mm of looseness throughout the entire range of motion.It was reported that during surgery the plan did not match the outcome and more tibia had to be removed to finish the procedure.
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H10: the device was used in treatment and it was reported that the gap planning graph did not represent the outcome after burring.Case log files and screenshots were not returned for evaluation.Dhr review found that the software version (r-3101) has been validated.A complaint history review found similar reports, this issue will continue to be monitored.A relationship between the device and the reported event could not be established.The naviopfs system for unicondylar knee replacement (ukr) (500001 revi) provides instructions for using the system and how to use it for implant planning and collecting range of motion data.This issue is an identified risk in within the risk assessment.The root cause of the issue could not be determined.A potential factor that could have contributed to the reported issue is if the join was overstressed during range of motion data collection.Per complaint details, this represents a procedure complication and does not represent a device malfunction.Based on the information provided, there was no surgical delay or patient injury/impact as a result of the reported event.Therefore, no further medical assessment is warranted.
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