BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK M2A MAGNUM HIP

    MDR report key: 3193352 · Received June 27, 2013

    Report

    Report Number
    0001825034-2013-02351
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    February 11, 2013
    Report Date
    October 14, 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
    US
    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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02351 & 05260 / 05262).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR (B)(6) REGARDING PATIENTS ENROLLED IN A (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. DURING POST OPERATIVE MONITORING AND TESTING A CYST AND ELEVATED METAL IONS WERE NOTED. THE CYST MEASURED 2.4 X 2.2 X 3 / 4.3 X 2.3 X 1.6. THESE FINDING WERE FOUND DUE TO FOLLOW UP TESTING. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR (B)(6) REGARDING PATIENTS ENROLLED IN A (B)(6) STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. DURING POST OPERATIVE MONITORING AND TESTING, A CYST AND ELEVATED METAL ION LEVELS WERE NOTED. THE CYST MEASURED 2.4 X 2.2 X 3 / 4.3 X 2.3 X 1.6. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292774 UNK M2A MAGNUM HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 597280

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization