BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIVATE REVERSE SHOULDER

    MDR report key: 11984316 · Received June 11, 2021

    Report

    Report Number
    1644408-2021-00567
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    KWS
    UDI-DI
    00190446257585
    PMA / PMN Number
    K172351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS AN INFECTION AND LOOSENING. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 2 YEARS AND 10 MONTHS APART. INITIAL OR PROLONGED HOSPITALIZATION WAS REQUIRED. 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 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 A NONCONFORMANCE ASSOCIATED WITH THE MAIN PART #509-03-432, AR, SMALL SOCKET INSERT, 32MM SEMI CONSTRAINED +4 EPLUS WHICH DOCUMENTS THAT OUT OF 20 PARTS LOT, 1 PART WAS REJECTED AND SCRAPPED ON ROUTER. 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 A REVIEW. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO AN INFECTION AND LOOSENING. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICES WERE THE SOURCE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION. 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. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - THE LINER, GLENOSPHERE, BASEPLATE AND SCREWS WERE REMOVED. THE PATIENT HAD A LONG, FULLY CEMENTED HUMERAL COMPONENT SO THAT WAS RETAINED. THERE WAS INFECTION PRESENT AND SEPTIC LOOSENING ON THE GLENOID SIDE IS WHY THE SHOULDER WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877417 ALTIVATE REVERSE SHOULDER AR, SMALL SOCKET INSERT, 32MM SEMI CONSTRAINED +4 EPLUS KWS ENCORE MEDICAL LP 509-03-432 954W1006 00190446257585

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R 506-03-114 LOT 831C1539| 506-03-122 LOT 833C1432| 506-03-126 LOT 834C1442| 508-32-101 LOT 862C2640| 508-32-204 LOT 769P1423