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.In the package insert under possible adverse effects, item 4 states: "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity." medical product - comp primary stem 16mm std catalog #: 113656 lot #: 110350, comp locking screw catalog #: 180501 lot #: 710430, comp non-lckng screw catalog #: 180509 lot #: 999860, comp rvrs shdr glen bsplt catalog #: 115330 lot #: 628500, comp non-lckng screw catalog #: 180508 lot #: 979470, comp rvs cntrl scr catalog #: 115381 lot #: 345270.This is 3 of 5 reports being filed for the same patient (reference 1825034-2017-00721 - 00725).
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