BEUDAMED
    FDA Adverse Event Summary report: N

    RSP SHOULDER

    MDR report key: 3000113 · Received March 12, 2013

    Report

    Report Number
    1644408-2013-00134
    Date Received
    March 12, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER TWO MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT; THE PARTS WERE RETURNED TO THE VENDOR. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 77TH COMPLAINT FOR THIS PART NUMBER: ONE FIT ISSUE, 41 DUE TO DISLOCATION, TWO DUE TO PAIN, SEVEN DUE TO INFECTION, SEVEN DUE TO TRAUMA, 12 FOR STABILITY/POOR JOINT, FOUR FOR DISSOCIATION, AND THREE WERE UNDETERMINED. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEMS WITH THE PRODUCT. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN DISLOCATION SUCH AS; LOOSE JOINT FROM INADEQUATE SOFT TISSUE AND PATIENT ACTIVITY.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103831 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW/NEUTRAL KWS ENCORE MEDICAL, L.P. 862C1203

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 508-00-032, LOT 855C1159