BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT

    MDR report key: 22336779 · Received June 26, 2025

    Report

    Report Number
    0001822565-2025-02154
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    June 5, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024145795
    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. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (5648920).

    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.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (5648920).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793940 CPT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. 65514628 00889024145795

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization| R