BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SHOULDER HUMERAL STEM GLOBAL

    MDR report key: 13001253 · Received December 14, 2021

    Report

    Report Number
    1818910-2021-27847
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 14, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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 · 0

    PATIENT WAS REVISED DUE TO INFECTED TOTAL SHOULDER. EXPLANTED ALL IMPLANTS, IMPLANTED COMPETITOR REVERSE SHOULDER. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015, DOR: (B)(6) 2021, RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903929 UNK SHOULDER HUMERAL STEM GLOBAL SHOULDER HUMERAL STEM HSD DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention 52 ANCHOR PEG GLENOID| 52X21 ECC GLOBAL ADVANTAGE HEAD| GLOBAL ADVANTAGE STEM SIZE 12