(b)(4).Medical product: g7 acetabular system dual mobility acetabular liner, catalog#: 110024462, lot#: 401090.G7 acetabular screw, catalog#: 010000998, lot#: 3801672.G7 acetabular screw, catalog#: 010000997, lot#: 3753689.G7 acetabular screw, catalog#: 010000999, lot#: 3787070.G7 acetabular screw, catalog#: 010000998, lot#: 3797747.G7 osseo ti 3 hole shell, catalog#: 110010243, lot#: 3795520.Act arctic e1 hip bearing, catalog#: ep-200146, lot#: 678440.Taperloc 133 fp type1 pps, catalog#: 51-100080, lot#: 3755902.Reported event was confirmed by review of x-rays and operative notes.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-04307, 11395, 11396.
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It was reported that patient was revised approximately 3 months post-operatively due to migration and malalignment of the dual mobility liner.Malalignment/migration were initially noted on radiographs ten days post-implantation.In initial operative notes, surgeon clearly states that there is a possibility of needing a head/liner exchange in future if position of liner changes or symptoms present from the hip.From the revision operative report: patient had significant tendinosis and partial fraying.There was significant metallosis in the hip joint from displacement of metal liner from the cup.Dual mobility head was removed.Trunnion was noted to be mildly scratched with stem well fixed.One of the screws was prominent in the shell and was most likely was the reason for displacement of the liner, according to surgeon.This screw was removed.
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