BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE ECC HD 44X21

    MDR report key: 7596620 · Received June 13, 2018

    Report

    Report Number
    1818910-2018-62079
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 15, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    HSD
    UDI-DI
    10603295005131
    PMA / PMN Number
    K992065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    REVISION S-FIT AND GLOBAL ADVANTAGE SHOULDER REPLACEMENT, (B)(6) PRIVATE (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2004. S-FIT GLENOID USE WITH GLOBAL ADVANTAGE STEM FOR ANATOMICAL SHOULDER REPLACEMENT 14 YEARS AGO. PATIENT EXPERIENCED PAIN ONSET AND WAS ADVISED TO REVISE DUE TO ROTATOR CUFF DEFICIENCY. THERE WAS POLY WEAR AND GLENOID WEAR TO THE POINT WHERE THERE WAS METAL ON METAL WITH THE PROSTHESIS. REVISED ALL IMPLANTS, WITH DELTA XTEND REVERSE SHOULDER. RELEVANT PATIENT PRE-EXISTING CONDITIONS/ COMORBIDITIES: ROTATOR CUFF DEFICIENCY. PATIENT INITIAL (B)(6). UNKNOWN JRN: (B)(4) S-FIT GLENOID BEARING 44X3 LOT # 1141284; UNKNOWN JRN: (B)(4) S-FIT MB GLENOID 44MM LOT # YMV-40; UNKNOWN JRN: NO PRODUCT CODE - 3.5X28 SCREWS FOR S-FIT - LOT # UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441270 GLOBAL ADVANTAGE ECC HD 44X21 GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS HSD DEPUY ORTHOPAEDICS, INC. 1818910  VY7GL1024 10603295005131

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention