Batch review performed on 24 may 2018: lot 155383: (b)(4) items manufactured and released on 03 december 2015.Expiration date: 2020-11-18.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs (b)(4) on 24 may 2018: two years after primary hybrid tha a revision surgery was performed, reportedly due to psoas impingement with the acetabular cup.This situation should not be attributed to a faulty device.Visual inspection performed by r&d product manager on 24 may 2018; on the ceramic femoral head, some slight signs can be noted on both the internal and external surfaces.They were probably caused during the revision surgery.On the liner, a sign relative to the insertion of a screw can be noted: it was plausibly inserted to extract the liner during the revision surgery.Two damaged portions can be noted on the base of the liner and on its internal surface.On the external surface around the pole, lipid absorption can be noted.Our cq department is performing dimensional controls on the part.To date, no conclusions can be drawn.
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Revision of ball head and liner 2 years after primary due to psoas impingement.Intraoperative clinical status looks like infected, histology macrophage infiltration, but the pathology results came back negative (no infection).Surgeon commented that he found debris from the inlay during the revision.
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