BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A HIP

    MDR report key: 3923730 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06089
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    January 7, 2014
    Report Date
    July 1, 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
    OH, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-06126 & 2014-06089).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2013 DUE TO AN ADVERSE REACTION TO METAL DEBRIS. THE ACETABULAR COMPONENT AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN, ADVERSE REACTION TO METAL DEBRIS AND ELEVATED METAL ION LEVELS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401819 UNKNOWN M2A HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R