On the literature article named "does the use of intraoperative pressure sensors for knee balancing in total knee arthroplasty improve clinical outcomes? a comparative study with a minimum two-year follow-up", it was reported that, one patient from the sensor balance group underwent a revision surgery due to aseptic loosening of the tibial component, which was replaced.The outcome of the patients is unknown.
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H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data provided was presented in the literature article named "does the use of intraoperative pressure sensors for knee balancing in total knee arthroplasty improve clinical outcomes? a comparative study with a minimum two-year follow-up".Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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