BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY ACETABULAR SYSTEM DUAL MOBILITY LINER 38MM C

    MDR report key: 22412448 · Received July 7, 2025

    Report

    Report Number
    0001825034-2025-01987
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 10, 2025
    Report Date
    November 10, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304703490
    PMA / PMN Number
    K150522
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: D4; G3; H2; H3; H4; H6. 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. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-1055 LOT# 3123626 CER BIOLOXD OPTION HD 28MM, CAT# 650-1068 LOT# 3111626 CER OPTION TYPE 1 TPR SLEVE +6, CAT# 51-145130 LOT# 6209866 TPRLC XR MP T1 PPS 13X111MM, CAT# 110010262 LOT# 6312347 G7 OSSEOTI MULTIHOLE 48MM C, CAT# 010000996 LOT# 6263545 G7 SCREW 6.5MM X 15MM, CAT#010001000 LOT# 6219960 G7 SCREW 6.5MM X 35MM, CAT# 010001000 LOT# 6245599 G7 SCREW 6.5MM X 35MM, CAT# 110031009 LOT# 65560533 28MM I.D. 38MM O.D. SIZE C BEARING. G2: FOREIGN: JAPAN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS NOT RETURNED BY THE SURGEON. 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 FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY THE PATIENT DISLOCATED. DURING THE CLOSED REDUCTION, THE BEARING AND HEAD DISASSOCIATED, AND THE PATIENT UNDERWENT A SECOND REVISION ON APPROXIMATELY 3 YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756644 G7 DUAL MOBILITY ACETABULAR SYSTEM DUAL MOBILITY LINER 38MM C PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 806990 00880304703490

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.