BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER GLENOID

    MDR report key: 7596597 · Received June 13, 2018

    Report

    Report Number
    1818910-2018-62076
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 15, 2018
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    HSD
    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, DAN POSEL, LAKE MACQUARIE 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 T. AGED 80 YEARS. 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
    438602 UNKNOWN SHOULDER GLENOID SHOULDER GLENOID HSD DEPUY FRANCE SAS 3003895575 YMV-40

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention