BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD STEM - 10X100MM

    MDR report key: 24845078 · Received April 10, 2026

    Report

    Report Number
    0001825034-2026-00911
    Event Type
    Injury
    Date Received
    April 10, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    UDI-DI
    00880304540354
    PMA / PMN Number
    K223631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. THIS REPORT WAS ORIGINALLY SUBMITTED UNDER THE WRONG COMPLAINT RECORDS: (B)(4) - 0001825034-2026-00515. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 110029824(967220). ASSOCIATED PRODUCT INFORMATION, PART (LOT): 130609(284030), 130611(522830), 00840001511(63164575), 00840009000(64759526), 00840009500(64737340). H6: PROPOSED ANNEX G CODE: MECHANICAL (G04)- STEM. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS BEING CONSIDERED FOR A REVISION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373746 COMPR SRS MOD STEM - 10X100MM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT ZIMMER BIOMET, INC. 652990 00880304540354

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other SEE H11.