BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A HIP

    MDR report key: 3981729 · Received August 5, 2014

    Report

    Report Number
    0001825034-2014-06844
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN, DATE IMPLANTED - UNKNOWN, INITIAL REPORTER - UNKNOWN, PMA/510(K) NUMBER / MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO INFECTION; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456772 UNKNOWN M2A HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R