BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP

    MDR report key: 3220796 · Received July 11, 2013

    Report

    Report Number
    0001825034-2013-02628
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE WAS DUE TO WEAR OF THE COMPETITOR'S POLYETHYLENE ACETABULAR LINER. THIS WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. 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 PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN 1987 WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET MODULAR HEAD. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO WEAR OF THE COMPETITOR'S ACETABULAR LINER. THE COMPETITOR LINER AND THE BIOMET MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT REQUIRES A REVISION DUE TO UNKNOWN REASONS. IT IS UNKNOWN WHETHER THE REVISION HAS TAKEN PLACE OR HAS BEEN SCHEDULED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320301 UNK HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R