BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD STEM - 11X200MM

    MDR report key: 24742908 · Received March 31, 2026

    Report

    Report Number
    0001825034-2026-00791
    Event Type
    Injury
    Date Received
    March 31, 2026
    Report Date
    March 31, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K223631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: ITEM # 211265, COMPR SRS MOD STEM - 11X200MM, LOT # UNKNOWN . H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - STEM. 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 CUSTOM ELBOW COMPONENTS WERE REQUESTED FOR A PATIENT WITH A TITANIUM ALLERGY. PREVIOUSLY IMPLANTED COMPONENTS HAD BEEN EXPLANTED PRIOR TO THE REQUEST. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801083 COMPR SRS MOD STEM - 11X200MM PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED JDC ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE