EQUINOXE

Description of Event or Problem

IT WAS REPORTED THAT A 58 YO MALE PATIENT, WHO HAD A LEFT PRIMARY TSA, UNDERWENT A REVISION TO REMOVE A STEMLESS PRIMARY TSA AND LASER CAGE GLENOID. THE SURGEON POINTED OUT IT WAS APPARENT THAT THE OVERHANG OF THE HEAD IMPLANT CONTRIBUTED TO THE FAILURE OF THE SUBSCAPULARIS. ONCE THE HEAD AND HUMERAL COMPONENT WERE REMOVED, THEY MOVED TO THE GLENOID WHERE THE LASER CAGE GLENOID WAS REMOVED WITH AN OSTEOTOME. THE CENTRAL PEG AND INFERIOR PEGS WERE EXPLANTED BUT THEY WERE UNABLE TO REMOVE THE SUPERIOR PEG WITHOUT CAUSING TOO MUCH DAMAGE, SO IT WAS LEFT IN. AN ABX SHOULDER SPACER WAS REIMPLANTED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE HEAD IMPLANT APPEARS TO BE DISLOCATED IN THE IMAGING. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE HOSPITAL WILL NOT RELEASE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

Additional Manufacturer Narrative

D10: 300-60-03 - STEMLESS HUMERAL COMP LASER CAGE, SIZE 3: (B)(6), 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM: (B)(6), 531-78-20 - SHOULDR GPS HEX PINS KIT: (B)(6), (B)(6) - GPS IMPLANT KIT V2: 11000922065. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.