BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 40MM D

    MDR report key: 21332495 · Received February 7, 2025

    Report

    Report Number
    0001825034-2025-00304
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    January 19, 2025
    Report Date
    May 1, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304703506
    PMA / PMN Number
    K150522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110010263 ITEM NAME G7 OSSEOTI MULTIHOLE 50MM D LOT # 6864425, EP-200146 ITEM NAME ACT ARTIC E1 HIP BRG 28X40MM LOT # 798670, 6364-2-228 ITEM NAME STRYKER V40 FEMORAL HEAD LOT # G8135927, 0580-1-044 ITEM NAME STRYKER EXETER V40 CEMENTED HIP STEM LOT # G8096480. G2: FOREIGN: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. IT WAS IDENTIFIED THAT ZIMMER BIOMET DEVICES WERE IMPLANTED WITH COMPETITOR DEVICES. AS PER IFU, THE BEARING SHOULD NOT BE USED WITH COMPONENTS OF ANY OTHER SYSTEM OR MANUFACTURER, UNLESS AUTHORIZED BY ZIMMER BIOMET. IT IS UNKNOWN IF THIS OFF LABEL USE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THE COMPLAINT CANNOT BE 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 THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248237 G7 DUAL MOBILITY LINER 40MM D PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 951570 00880304703506

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Hospitalization| R PLEASE SEE H11