BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR STD NECK

    MDR report key: 4200697 · Received October 24, 2014

    Report

    Report Number
    0001825034-2014-08348
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "MATERIAL SENSITIVITY REACTIONS."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0001825034-2014-08256. ALL ADDITIONAL INFORMATION WILL BE REPORTED ON 0001825034-2014-08256.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL LEFT HIP PROCEDURE ON (B)(6) 1999. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO ALLEGATIONS OF METALLOSIS. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679323 32MM MOD HEAD COCR STD NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 227370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R