BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3161856 · Received June 6, 2013

    Report

    Report Number
    1644408-2013-00316
    Event Type
    Other
    Date Received
    June 6, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 24, 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 IDENTIFIED AS A DAMAGED SUBSCAPULAR REPAIR AFTER 1.8 MONTHS 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 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 31ST COMPLAINT FOR THIS PRODUCT: ONE DUE TO A FIT ISSUE, 6 REVISIONS, 12 DUE TO DISLOCATION, FOUR DUE TO INFECTION, TWO FOR DEVICE LOOSENING, ONE FOR SURGICAL TECHNIQUE, THREE FOR STABILITY/POOR JOINT, AND ONE INDETERMINATE. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE SUBSCAPULAR REPAIR WAS MOST LIKELY DUE TO THE PATIENT FALLING. THE INFORMATION REVIEWED SHOWED THAT THE PRODUCT USED IN THE SURGERY MET ALL DESIGN, MATERIAL, AND MANUFACTURING SPECIFICATIONS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT FELL DOWN AND DAMAGED HIS SUB-SCAPULAR REPAIR, THE SURGEON WANTED TO SWAP OUT THE POLY AND CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251443 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 856C1043

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 508-00-004: LOT 852C1096