BEUDAMED
    FDA Adverse Event Summary report: N

    RSP SHOULDER

    MDR report key: 3050875 · Received April 10, 2013

    Report

    Report Number
    1644408-2013-00207
    Date Received
    April 10, 2013
    Date of Event
    April 3, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 1.5 YEARS OF PATIENT USE. 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 NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 81ST COMPLAINT FOR THIS PART NUMBER: ONE DUE TO A FIT ISSUE, 44 DUE TO DISLOCATION, TWO DUE TO PAIN, SEVEN DUE TO INFECTION, SEVEN DUE TO TRAUMA, 12 FOR STABILITY/POOR JOINT, FOUR DUE TO DISSOCIATION, AND THREE WERE INDETERMINATE. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS DUE TO TRAUMA AS A RESULT OF THE PATIENT FALLING. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - FOLLOWING THE ORIGINAL SURGERY THE PATIENT WAS DOING WELL UP UNTIL HE FELL AND DISLOCATED HIS SHOULDER. THE SURGEON WAS ABLE TO RELOCATE THE SHOULDER, BUT THE PATIENT WAS STILL IN PAIN AND FELT UNSTABLE. THE SURGEON THEN CHANGED THE NEUTRAL SHELL TO A +4 SHELL, AND REPLACED THE POLYETHYLENE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153728 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 855C1067

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 508-00-000, LOT 848C1145