BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS TUMOR BDY - 51MM

    MDR report key: 24639380 · Received March 19, 2026

    Report

    Report Number
    0001825034-2026-00627
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 19, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304540781
    PMA / PMN Number
    K173411
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: COMPR SRS SEAS HMRL HEAD 40X15 CAT # 211256 LOT # 66771580. G2: FOREIGN - EVENT OCCURRED IN JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY FOUR WEEKS POST-IMPLANTATION DUE TO DETACHMENT OF THE MODULAR HEAD. THE PATIENT WAS EXPERIENCING PAIN PRIOR TO THE REVISION. THE HEAD AND BODY WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700873 COMPR SRS TUMOR BDY - 51MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 993050 00880304540781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.