BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 50D

    MDR report key: 8172851 · Received December 18, 2018

    Report

    Report Number
    3002806535-2018-01281
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 28, 2018
    Report Date
    July 12, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWZ
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). MEDICAL PRODUCT: DELTA CER FM HD036/+4MM 12/14 , CATALOG #: 650-0838, LOT #: 2017020568. MEDICAL PRODUCT: G7 NEUTRAL E1 LINER 36MM D, CATALOG #: 010000856, LOT #: 6014239. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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.

    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). 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

    REVISION DUE TO LOOSENING, THE LIKELY RESULT OF AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013053 G7 BISPHERICAL SHELL 50D PROSTHESIS, HIP KWZ BIOMET UK LTD. N/A 3983925

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R