It was reported that total hip arthroplasty was performed with hipalign, supine approach.The surgeon planned that target cup angle was 40/15 degrees.The procedure was proceeded in accordance with the target cup angle.After cup impaction, the navigation showed that the cup was installed with 39/14 degrees (cup angle).Postoperatively, he confirmed x-ray photos of the cup angle and abduction angle of the cup was 56 degrees.
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An investigation of returned navigation unit log file found a significant change in cup values were displayed after the cup was impacted.The root cause of this issue is navigating the cup with the sensor attached to the impactor while impacting.Orthalign does not recommend navigating during impaction, it can cause damage and loss of navigation accuracy.Orthalign recommends navigating, taking the sensor off the impactor, then impacting.After impaction, the "check cup" feature can be utilized to verify results.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.
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