BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3900731 · Received June 27, 2014

    Report

    Report Number
    1644408-2014-00397
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS A CHRONIC INFECTION. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 IMPLANT DEVICE HISTORY RECORDS (DHR'S) AND PRODUCT COMPLAINT REPORT (PCR) DATABASE RECORDS SHOW THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMR'S) ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO AN INFECTION. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN IT'S EXPIRATION DATE AT THE TIME OF USE DURING THE PREVIOUS SURGERY. THERE WERE NO FINDINGS DURING THIS INVESTIGATION THAT INDICATE THAT THE REPORTED DEVICES WERE THE SOURCE/ROOT CAUSE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. 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 HAVING A CHRONIC SHOULDER INFECTION. THE SURGEON NOTICED THE INFECTION DURING A PRIOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378318 RSP SHOULDER RSP GLENOID HEAD W/RETAINING SCREW / -4MM OFFSET 32MM KWS ENCORE MEDICAL, L.P. 864C1168

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R 506-03-126,LOT 834C1058| 806-03-118,LOT 832C1036| 508-00-008,LOT 854C1024| 506-03-122,LOT 833C1053