BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE TOTAL SHOULDER

    MDR report key: 3588923 · Received January 14, 2014

    Report

    Report Number
    MW5033928
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    September 3, 2013
    Report Date
    January 9, 2014
    Manufacturer
    DJO LLC
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISSOCIATION OF THE GLENOID HEAD FROM THE BASE PLATE OF A REVERSE SHOULDER PROSTHESIS. PREVIOUSLY, PATIENT HAD TOTAL LOSS OF THE ROTATOR CUFF AFTER MULTIPLE SURGERIES ELSEWHERE COMPLICATED BY INFECTION, LEAVING THE SHOULDER WITH PSEUDOPARALYSIS. WE PERFORMED A REVERSE TOTAL SHOULDER ON (B)(6) 2013 USING THE REVERSE SHOULDER PROSTHESIS. THE DJO REPRESENTATIVE WAS PRESENT IN THE OPERATING ROOM. THE R9P 6.5 GUIDE TAP WAS POSITIONED. THE FACE OF THE GLENOID WAS REAMED USING THE RSP GLENOID REAMER. THE BASEPLATE WAS VERY SECURELY FIXED AND FULLY SEATED FLUSH WITH THE REAMED GLENOID. ATTEMPTED FURTHER ADVANCEMENT OF THE BASEPLATE ROTATED THE ENTIRE SCAPULA. THE FOUR PERIPHERAL (LOCKING) SCREWS WERE PLACED SECURELY. THE RSP BASEPLATE RIM PLANER WAS USED TO MANUALLY REAM AROUND THE RIM OF THE BASEPLATE TO REMOVE ANY BONE AND SOFT TISSUE TO PREVENT IMPINGEMENT WHEN IMPLANTING THE GLENOID HEAD. ALL SOFT TISSUE WAS REMOVED FROM THE CIRCUMSTANCE OF THE BASEPLATE. THE BASEPLATE WAS CLEANED AND DRIED. THE 36 NEUTRAL GLENOID HEAD WAS VIGOROUSLY IMPACTED WITH FOUR FIRM TAPS WITH THE IMPACTOR AND NOTED TO SIT FLUSH ON THE BASEPLATE. VIGOROUS TRACTION WAS APPLIED TO THE GLENOID HEAD AND IT COULD NOT BE SEPARATED FROM THE BASEPLATE. CAREFUL INSPECTION AROUND THE PERIPHERY OF THE BASEPLATE SHOWED THE HEAD WAS WELL SEATED. THE RETAINING SCREW WAS INSERTED WITH THE TORQUE-LIMITING DRIVER. THE HEAD WAS AGAIN IMPACTED AND THE SECURITY OF THE RETAINING SCREW WAS AGAIN CHECKED WITH THE TORQUE-LIMITING DRIVER. PROCEDURE CONCLUDED WELL AND THE PATIENT RECOVERED NICELY. HIS POSTOPERATIVE FILMS SHOWED COMPLETE SEATING OF THE GLENOID HEAD ON THE BASEPLATE. WITHIN 2 MONTHS, THE PATIENT HAD REGAINED FULL ACTIVE ELEVATION WITH MINIMAL DISCOMFORT. HOWEVER, AFTER AN ACCIDENT IN WHICH THE PATIENT APPLIED MODERATE IMPACT TO SHOULDER WHILE OPENING A PROPANE TANK, THE GLENOID HEAD DISSOCIATED FROM THE BASEPLATE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. THE BASEPLATE WAS SECURED AND NOT DAMAGED, THE SCREW WAS LOOSE IN THE WOUND BUT NOT DAMAGED OR STRIPPED. TRIAL RE-IMPLANTATION OF THE GLENOID HEAD AGAIN REVEALED THAT IT COULD NOT BE PULLED OFF BY HAND AND CAREFUL INSPECTION OF THE RIM OF THE BASEPLATE FAILED TO REVEAL ANY BONE OR SOFT TISSUE THAT WOULD OBVIOUSLY BLOCK COMPLETE SEATING. IT WAS NOTED, HOWEVER THAT THE BASE PLATE RIM PLANER PROVIDED IN THE INSTRUMENT SET HAS A SMALLER DIAMETER THAN THAT OF THE 36 NEUTRAL GLENOID HEAD SO THAT IT DOES NOT ASSURE COMPLETE REMOVAL OF POTENTIALLY BLOCKING BONE. WE THEN USED A PINECONE BUR TO VIGOROUSLY RECESS THE BONE AROUND THE PERIPHERY OF THE BASE PLATE. WE THEN INSERTED A NEW 36 NEUTRAL GLENOID HEAD. AGAIN THIS COULD NOT BE PULLED OFF BY HAND. THE SETSCREW WAS PLACED. AGAIN POST OPERATIVE X-RAYS SHOWED SATISFACTORY SEATING OF THE GLENOID HEAD. AT THIS POINT THE PATIENT'S ARM REMAINS IN A SLING FOR SIX WEEKS AFTER SURGERY BEFORE ACTIVITY IS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34735 REVERSE TOTAL SHOULDER REVERSE TOTAL SHOULDER KWS DJO LLC
    34736 REVERSE TOTAL SHOULDER REVERSE TOTAL SHOULDER KWS DJO, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention