BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3884419 · Received June 19, 2014

    Report

    Report Number
    1644408-2014-00380
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS INSTABILITY AFTER 1.6 YEARS OF IMPLANT USE. THE HEALTHCARE PROFESSIONAL INDICATED 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 AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED (B)(4) NON-CONFORMING MATERIAL REPORT (NCMR) ASSOCIATED WITH THIS PRODUCT. NCMR (B)(4) SHOWED (B)(4) PARTS (PART NUMBER: 50800004) REWORKED FOR NOT MEETING MATERIAL SPECIFICATION (MS) MS#(B)(4). A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT FOR THIS PART NUMBER FROM THIS LOT. THE ROOT CAUSE FOR THE INSTABILITY WAS REPORTED AS A FALL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT FALLING AND COMPLAINING OF INSTABILITY IN THE JOINT/PROSTHESIS. THE SURGEON REVISED THE CUP AND POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362019 RSP SHOULDER RSP HUMERAL SOCKET SHELL, +4MM OFFSET KWS ENCORE MEDICAL, L.P. 852C1087

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention (B)(4)