BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 12063421 · Received June 24, 2021

    Report

    Report Number
    1644408-2021-00608
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    KWS
    UDI-DI
    00888912143202
    PMA / PMN Number
    K960906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS GLENOID FAILURE. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 10 YEARS AND 3 MONTHS APART. 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 DEVICES WERE DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOW THAT THE REPORTED COMPONENTS USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS AN NCMR#(B)(4) ASSOCIATED WITH THE MAIN PART #500-04-146, GLENOID, UNIFORM, PEGGED 46MM CM FOUNDATION SHOULDER, WHICH DOCUMENTS THAT OUT OF 20 PARTS LOT, 1 PART WAS REJECTED AND SCRAPPED DUE TO MULTIPLE TOOL MARKS ON RADIUS "E". ALL OTHER ITEMS IN THE LOT WERE MET WITH FIT, FORM AND FUNCTION REQUIREMENTS. THE DEVICES WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICES SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING ARE VIEW. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO GLENOID FAILURE. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICES WERE DEFECTIVE. 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 EVENT. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL SUCH AS POOR BONE DENSITY, INADEQUATE SOFT TISSUE SUPPORT, PROLONGED OVERHEAD ACTIVITIES, PATIENT ACTIVITIES OR TRAUMA. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO GLENOID FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960550 FOUNDATION SHOULDER GLENOID, UNIFORM, PEGGED 46MM CM FOUNDATION SHOULDER KWS ENCORE MEDICAL LP 500-04-146 A1000000 00888912143202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention