BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITI 40 PEGGED GLENOID

    MDR report key: 3133776 · Received May 23, 2013

    Report

    Report Number
    3004983210-2013-00006
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 21, 2012
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    PMA / PMN Number
    K060988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    PT WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2011. INITIALLY THE PT DID WELL AND RECOVERED AT AN ACCEPTABLE PACE; HOWEVER, AT HER THREE MONTH FOLLOW-UP VISIT WE FELT SHE HAD NOT ACHIEVED THE RANGE OF MOTION WHICH WE WOULD EXPECT AT TWELVE WEEKS AFTER SURGERY, AND SHE WAS STILL USING HER PAIN MEDICATION TO SLEEP. A TRIAL OF DIRECTED PHYSICAL THERAPY DID NOT IMPROVE HER PAIN, AND HER LIMITED MOTION WAS CONCERNING FOR POSSIBLE SUBSCAPULARIS INSUFFICIENCY (THE SUBSCAPULARIS IS DETACHED AND RE-ATTACHED AS PART OF THE SURGICAL APPROACH). WE OBTAINED A CT SCAN OF HER OPERATIVE SHOULDER AND IT APPEARS BOTH ON PHYSICAL EXAM AND ON THE CT SCAN THAT THE IMPLANT ITSELF HAS APPROPRIATE ALIGNMENT AND IS STABLE BUT A PORTION OF THE SUBSCAPULARIS IS NOT INTACT. THE PT IS SCHEDULED FOR AN ARTHROSCOPIC INTERVENTION TO REPAIR HER SUBSCAPULARIS AND DEBRIDE SCAR TISSUE WHICH MAY ALSO BE CONTRIBUTING TO HER LIMITED MOTION. INITIALLY, PT DID WELL AFTER THE REPAIR IN (B)(6). PT RETURNED TO CLINIC WITH INCREASED SHOULDER PAIN AND DECREASED SHOULDER RANGE OF MOTION. REVIEW OF CT SCAN ILLUSTRATED INSUFFICIENCY OR FAILURE OF ROTATOR CUFF MUSCULATURE. RIGHT TOTAL SHOULDER REVISION WITH REMOVAL OF SIMPLICITI DEVICE AND AFFINITI GLENOID. CONVERSION TO REVERSE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229915 AFFINITI 40 PEGGED GLENOID NONE KWS TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention