BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI MULTIHOLE 56MM F

    MDR report key: 17779679 · Received September 20, 2023

    Report

    Report Number
    0001825034-2023-02177
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 25, 2023
    Report Date
    October 17, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868356049
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 20-8060-303-00 LOT# UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 02178. G2: FOREIGN - JAPAN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE SHELL REMAINS ASSEMBLED WITH THE INSERTER. REVIEW OF THE DEVICE HISTORY RECORD(S) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A HIP PROCEDURE. DURING THE PROCEDURE, THE SHELL COULD NOT BE DISASSEMBLED FROM THE INSERTER AND THE SHELL COULD NOT BE IMPLANTED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83411 G7 OSSEOTI MULTIHOLE 56MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65788475 00887868356049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown