BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FM HD 036/+4MM 12/14

    MDR report key: 8256129 · Received January 17, 2019

    Report

    Report Number
    3002806535-2019-00069
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    November 28, 2018
    Report Date
    July 12, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO LOOSENING AND INFECTION. ACETABULAR SHELL, ACETABULAR LINER AND FEMORAL HEAD WERE EXPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: G7 BISPHERICAL SHELL 50D, CATALOG #: 110017331, LOT #: 3983925, MEDICAL PRODUCT: G7 NEUTRAL E1 LINER 36MM D, CATALOG #: 010000856, LOT #: 6014239. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO LOOSENING AND INFECTION. ACETABULAR SHELL, ACETABULAR LINER AND FEMORAL HEAD WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50419 DELTA CER FM HD 036/+4MM 12/14 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2017020568

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R