Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions.¿ medical product - comprehensive locking screw catalog #: 180502, lot #:388400; comprehensive locking screw catalog #: 180500, lot #: 828340; comprehensive reverse central screw ,catalog #: 115383, lot #: 843190; comprehensive reverse shoulder 9 in steinmann catalog #: 405800, lot #: 904720; comprehensive primary stem 10 mm mini catalog #: 113630, lot #: 114710; comprehensive reverse shoulder glenosphere std 36 mm catalog #: 115310, lot #: 603120, comprehensive reverse fixed locking screw catalog #: 180500 lot #: 172380, comprehensive reverse tray co 44 mm catalog #: 115370 ,lot #: 460110; comprehensive non-locking screw catalog #: 180507 lot #: 258080; comprehensive reverse central screw catalog #: 115382, lot #: 602710.This is 2 of 2 reports being filed for the same patient (reference 1825034-2017-00114 / 00115).This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.
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