BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A MAGNUM HIP

    MDR report key: 3192174 · Received June 27, 2013

    Report

    Report Number
    0001825034-2013-02308
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS LIMITED INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. DATE EXPLANTED. MANUFACTURE DATE ¿ UNKNOWN. BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR. (B)(6) REGARDING PATIENTS ENROLLED IN A (B)(6) CLINICAL STUDY. PLEASE SEE ATTACHED ABSTRACT TITLED ¿PREVALENCE AND PREDICTORS OF PSEUDOTUMOR AND ELEVATED METAL ION LEVELS FOLLOWING LARGE-DIAMETER HEAD METAL-ON-METAL TOTAL HIP ARTHROPLASTY¿.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR. (B)(6) REGARDING PATIENTS ENROLLED IN A (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE DUE TO PAIN AND RECURRENT FLUID COLLECTIONS. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291802 UNKNOWN M2A MAGNUM HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R