BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3180064 · Received June 13, 2013

    Report

    Report Number
    1644408-2013-00322
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 2.9 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF BY THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 82ND COMPLAINT FOR THIS PRODUCT: ONE FIT ISSUE, 45 DUE TO DISLOCATION, TWO DUE TO PAIN, EIGHT DUE TO INFECTION, SEVEN DUE TO TRAUMA, 12 FOR STABILITY/POOR JOINT ISSUES, THREE FOR DISSOCIATION, THREE INDETERMINATE, AND ONE REVISION. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS MOST LIKELY DUE TO THE PATIENT'S ANATOMY. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - MECHANICAL FAILURE DUE TO THE PT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269508 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW/NEURTRAL KWS ENCORE MEDICAL, L.P. 54033071

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 508-00-032, LOT 54041295| 508-00-000, LOT A1000001