BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT

    MDR report key: 23145233 · Received September 25, 2025

    Report

    Report Number
    0002648920-2025-00259
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    June 5, 2025
    Report Date
    September 25, 2025
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K191735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 00877704004 LOT: 3052345 BIOLOX® OPTION, HEAD, XL. G2: FOREIGN ¿ AUSTRALIA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04)- STEM. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED CERAMIC HEAD AND SHELL WITH BIO-DEBRIS ON THE DEVICES. PICTURES WERE NOT PROVIDED FOR THE STEM. NO FURTHER EVALUATION CAN BE MADE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED FOR THIS SPECIFIC EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT CONFIRMED. 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 FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384903 CPT PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. 65514628

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H