BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 23630945 · Received November 24, 2025

    Report

    Report Number
    0001825034-2025-03759
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    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). H10: ACT ARTIC E1 HIP BRG 28X38MM, ITEM: EP-200144, LOT: 902410, DELTA CER FEM HD 28/0MM T1, ITEM: 650-1158, LOT: 2015020327. G2: JAPAN. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED HEAD AND BEARING COMPONENTS. THE BEARING COMPONENT IS SEEN FRACTURED OFF THROUGH TO THE CENTER AND A SMALL FRACTURE ON THE RIM, AND DEFORMATION SEEN ON THE INNER RIM. NO PRODUCT WAS RETURNED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE CUSTOMER INDICATED THAT THE PRODUCT LOCATION IS UNKNOWN; THEREFORE, IT WAS NOT RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, THE BEARING AND HEAD WERE REPLACED, AND THE OPERATION WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THAT THE BEARING WAS DAMAGED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629704 UNKNOWN CUP PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. UNKNOWN

    Patients

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