BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI

    MDR report key: 23934119 · Received December 31, 2025

    Report

    Report Number
    0001825034-2025-04248
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    December 5, 2025
    Report Date
    March 25, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868356025
    PMA / PMN Number
    K140669
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 110024463 LOT# 67337776 G7 DUAL MOBILITY LINER 42MM E CAT# 110031011 LOT# 67121610 VIVACIT-E DM BEARING 28X42MM CAT# 65020073 LOT# 163660 BIOMET MODULAR HEAD -6MM TYPE 1 TAPER 28M CAT# 51-116110 LOT# 7872145 TPRLC 133 MP TYPE1 BM SO 11.0 G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G3, G6, H2, H3, H4, H6, H11. D10: CAT#: 110024463; LOT#: 67337776; G7 DUAL MOBILITY LINER 42MM E. CAT#: 110031011; LOT#: 67121610; VIVACIT-E DM BEARING 28X42MM. CAT#: 65020073; LOT#: 163660; BIOMET MODULAR HEAD -6MM TYPE 1 TAPER 28M. CAT#: 51-116110; LOT#: 7872145; TPRLC 133 MP TYPE1 BM SO 11.0. UNKNOWN SCREWS (X3). VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE ACETABULAR COMPONENTS (SHELL, LINER, BEARING, SCREWS AND HEAD) AND STEM HAVE BEEN REVISED AND ARE COVERED IN BIODEBRIS. NO OTHER SIGNIFICANT FINDINGS NOTED ON THE SHELL OR SCREWS FROM THE IMAGE PROVIDED RELATED TO THE REPORTED ISSUES. NO FURTHER OBSERVATIONS CAN BE MADE BASED ON THE IMAGE ALONE. NO PRODUCT WAS RETURNED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 APPROXIMATELY THREE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO THE CUP DISSOCIATING FROM THE ACETABULAR WALL. THE CUP WAS NOT SEATED. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564001 G7 OSSEOTI PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 66440602 00887868356025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H