BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 4132499 · Received October 1, 2014

    Report

    Report Number
    1644408-2014-00598
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K111061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS AN INFECTION. THE PREVIOUS SURGERY AND THE REVISION DETAILED IN THIS INVESTIGATION OCCURRED 5.5 MONTHS APART. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE POSSIBLE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. 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 IMPLANT DEVICE HISTORY RECORDS (DHR'S) AND PRODUCT COMPLAINT REPORT (PCR) DATABASE SHOWS 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 THIS PRODUCT. THE DEVICE AND ITS APPLICABLE CONCOMITANT DEVICE WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN THEIR RESPECTIVE EXPIRATION DATES AT THE TIME OF USE DURING THE PREVIOUS SURGERY. THERE WERE NO FINDINGS DURING THIS INVESTIGATION THAT INDICATE THAT THE REPORTED DEVICE WAS THE 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 AN INFECTION THE SURGEON EXCHANGED THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611943 RSP SHOULDER RSP MONOBLOCK +8MM SPACER KWS ENCORE MEDICAL, L.P. 142G1068

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4), LOT 922F1036