BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 3 HOLE SHELL 52MM E

    MDR report key: 21665460 · Received March 21, 2025

    Report

    Report Number
    0001825034-2025-00778
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 21, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868355382
    PMA / PMN Number
    K140669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 010000935 G7 HI-WALL E1 LINER 36MM E 6923381. 0100561217 WAGNER CONE PROSTHESIS®, 125°, UNCEMENTED, ø 17, TAPER 12/14 3148141. 00877503603 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14 3136761 G2: FOREIGN: AUSTRALIA . 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. AN ADEQUATE COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED AS THE COMPLICATION, FAILURE MODE, AND/OR HARM EXPERIENCED BY THE USER IS UNKNOWN. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR UNKNOWN REASONS. THE STEM WAS THE IMPACTED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797594 G7 OSSEOTI 3 HOLE SHELL 52MM E PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A 7480872 00887868355382

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Required Intervention| H SEE H11 NARRATIVE.