This follow-up report is being submitted to relay additional information.Concomitant medical product-femur cemented posterior stabilized (ps) standard right size 11 catalog# 42500607002 lot# 62767613, articular surface fixed bearing posterior stabilized (ps) right 10 mm height catalog# 42522401010 lot# 62720734, palacos rg 1x40 single catalog# 00111314001 lot# 78714386 qty 2.No product was returned; visual and dimensional evaluations could not be performed.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 is required.Per the packaging insert associated with the device loosening and malalignment of the device are known inherent risks of the procedure.However, a definitive root cause cannot be determined at this time.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: 0001822565-2016-03931, 0001822565-2017-05610, 0001822565-2017-05611.
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