BEUDAMED
    FDA Adverse Event Summary report: N

    RSP SHOULDER

    MDR report key: 2993309 · Received March 7, 2013

    Report

    Report Number
    1644408-2013-00131
    Date Received
    March 7, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A DISLOCATION AFTER EIGHT DAYS OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS NOT AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION AND WAS KEPT BY THE HOSPITAL. 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 29TH COMPLAINT FOR THIS PART NUMBER: 12 DUE TO DISLOCATION, FIVE FOR INSTABILITY/POOR JOINT, FOUR DUE TO INFECTION, THREE FOR A LABELING ERROR, ONE HEMATOMA, ONE DUE TO DISSOCIATION, ONE REVISION, ONE OFF-LABEL USE, AND ONE DUE TO WEAR. THE ROOT CAUSE FOR THE DISLOCATION WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT DISLOCATED HER SHOULDER A FEW DAYS AFTER THE INITIAL SURGERY. THERE WAS NO FAILURE WITH THE POLY; THE SURGEON CHANGED THE SIZE TO PREVENT FUTURE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97314 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 856C1051

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention