BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY PLUG SM 8-10MM

    MDR report key: 24532542 · Received March 6, 2026

    Report

    Report Number
    0001825034-2026-00514
    Event Type
    Injury
    Date Received
    March 6, 2026
    Report Date
    March 6, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDS
    UDI-DI
    00880304005631
    PMA / PMN Number
    K800144
    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. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 211237(652990). 130611(522830). 110029824(967220). ASSOCIATED PRODUCT INFORMATION, PART (LOT): 00840001511(63164575). 00840009000(64759526). 00840009500(64737340). 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 DUE TO UNKNOWN REASONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593634 INTRAMEDULLARY PLUG SM 8-10MM NAIL, FIXATION, BONE JDS ZIMMER BIOMET, INC. 284030 00880304005631

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other