TORNIER FLEX SHOULDER SYS REVINSERT 36MM 6TH B 12.5DG

Additional Manufacturer Narrative

UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT REVERSE SHOULDER REPLACEMENT FOLLOWING A FRACTURE OF THE LEFT PROXIMAL HUMERAL HEAD. IN RECENT MONTHS, THE PATIENT EXPERIENCED SHOULDER INSTABILITY, RECURRENT DISLOCATIONS, AND PAIN. DURING THE REVISION PROCEDURE, THE PROSTHETIC SHOULDER JOINT WAS FOUND TO BE EASILY DISLOCATED WITH GROSS SOFT TISSUE LAXITY. ALL IMPLANTED COMPONENTS WERE WELL FIXED, AND NO POLYETHYLENE WEAR WAS OBSERVED. THE FLEX REVERSED TRAY, FLEX REVERSED INSERT, AND PERFORM REVERSED GLENOID STANDARD GLENOSPHERE WERE REMOVED AND REPLACED WITH A PERFORM REVERSED 36 MM ECCENTRIC GLENOSPHERE, LOW OFFSET +0 MM REVERSED TRAY, AND 36 MM/6 MM RETENTIVE B ANGLE POLYETHYLENE INSERT. ALL REMAINING IMPLANTS WERE LEFT IN PLACE. FOLLOWING IMPLANTATION OF THE NEW COMPONENTS, THE SHOULDER WAS REDUCED SUCCESSFULLY AND WAS STABLE THROUGHOUT THE FULL RANGE OF MOTION.