BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 6076682 · Received November 3, 2016

    Report

    Report Number
    1644408-2016-00835
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 5, 2016
    Report Date
    August 5, 2022
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    UDI-DI
    00888912024891
    PMA / PMN Number
    K080402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10: ADDING CONCOMITANT PART 402439.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS AN INFECTION. THE PREVIOUS SURGERY AND THE REVISION DETAILED IN THIS INVESTIGATION OCCURRED OVER 6.8 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 (DHRS) 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 (NCMRS) 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 DEVICE WAS THE ROOT CAUSE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION. IT WAS REPORTED, "THERE WAS NO PRODUCT ISSUE. THE ITEMS WERE USED AS A TEMPORARY SPACER WHILE THE PATIENT WAS TREATED FOR AN 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 - THERE WAS NO PRODUCT ISSUE. THE PARTS REPORTED ON THIS REPORT WERE USED AS A TEMPORARY SPACER WHILE THE PATIENT WAS TREATED FOR AN INFECTION WHICH WAS FOUND DURING THE ORIGINAL SURGERY ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727974 TURON SHOULDER TURON PRIMARY HUMERAL STEM, SZ 10 KWS ENCORE MEDICAL, L.P. 520-01-010 455G1181 00888912024891

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention 402439 COBALT-G MV BONE CEMENT 40GM B| 520-00-000, LOT 878C1538| 520-46-020, LOT 919C1042A| 520-00-000, LOT 878C1538| 520-46-020, LOT 919C1042A