(b)(4).Multiple mdr's were filed for this event.Please see: 0001825034-2018-05021, 0001825034-2018-05022, 0001825034-2018-05023, 0001825034-2019-02694.Concomitant medical products: catalog # 113648, comprehensive primary stem 8 mm std, lot # 104520.Catalog # 118001, versa-dial/comprehensive ti standard taper, lot # 201410.Catalog # xl-115363, arcom xl 44-36 standard humeral bearing, lot # 011140.Catalog # 115340, comprehensive reverse humeral ti tray 44 mm, lot # 492370.Catalog # 115330, comprehensive reverse shoulder baseplate, lot # 550050.Catalog # 180501, fixed locking screw, lot # 468580.No device was returned for examination.Medical records were reviewed and confirmed device disassociation and dislocation with associated metallosis.Review of the device history records identified no related deviations or anomalies during manufacturing.Root cause remains undetermined.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.
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The patient was revised to address dislocation, disassociation, and subsequent metallosis.Glenosphere was found disassociated, shoulder did have significant dusky grey material which was consistent with metallosis, area was wide debrided, and copiously irrigated with antibiotic irrigation, stem and glenoid baseplate were well fixed.No intraoperative complications.No further information is available at the time of this reporting.
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