BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FREEDOM CONST E1 LNR 36MM G

    MDR report key: 18326596 · Received December 14, 2023

    Report

    Report Number
    0001825034-2023-02976
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    November 23, 2023
    Report Date
    December 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THE CURRENT PARENT COMPLAINT FILE. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER 1825034 BIOMET UNDER A DIFFERENT COMPLAINT NUMBER.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 802403603 CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS 3041611 G2: FOREIGN: AUSTRALIA MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 02974 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH UNKNOWN ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED SEVEN MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266431 G7 FREEDOM CONST E1 LNR 36MM G PROTHESIS, HIPS PBI ZIMMER BIOMET, INC. N/A 6771746

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown Hospitalization| R