BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 6694579 · Received July 7, 2017

    Report

    Report Number
    1644408-2017-00545
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 7, 2017
    Report Date
    August 24, 2017
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    KWS
    UDI-DI
    00888912024389
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE PART AND LOT NUMBER WAS REPORTED AS 506-03-0122, LOT 830C1271 SHOULD BE 506-03-122, LOT 832C1271. MANUFACTURER NARRATIVE: THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS AN INFECTION. THE PREVIOUS SURGERY AND THE REVISION DETAILED IN THIS INVESTIGATION OCCURRED 5.8 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 INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS 10 MINUTE 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) 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. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE IN NEED OF REVIEW. 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. 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 INFECTED TOTAL SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474867 RSP SHOULDER STEM, HUMERAL SIZE8 RSP KWS ENCORE MEDICAL L.P. 506-00-008 814C1191 00888912024389

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 415-00-120,LOT 7714394| 506-03-0122,LOT 830C1271| 506-03-118,LOT 832C1275| 506-03-130,LOT 835C1212| 506-03-134,LOT 836C1051| 508-00-000,LOT 848C1948| 508-00-032,LOT 855C1147| 508-32-101,LOT 862C2236| 508-32-104,LOT 866C2151