BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 CURVED ACET SHELL INSERTER

    MDR report key: 5018589 · Received August 20, 2015

    Report

    Report Number
    0001825034-2015-03683
    Event Type
    Injury
    Date Received
    August 20, 2015
    Report Date
    September 4, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LKD
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON HAS EXPERIENCED FRACTURE OF THE IMPACTOR WHEN MEDIALIZING THE ACETABULAR CUP DURING TOTAL HIP ARTHROPLASTY PROCEDURES. THERE HAS BEEN NO REPORTED INJURIES TO PATIENTS AS A RESULT. FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552210 G7 CURVED ACET SHELL INSERTER PROSTHESIS, HIP LKD BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention