BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HEAD -3MM NK

    MDR report key: 4192492 · Received October 22, 2014

    Report

    Report Number
    0001825034-2014-08291
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2012
    Report Date
    March 31, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INITIAL REPORTER AND HOSPITAL ADDRESS.

    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

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM MEANDER MEDISCH CENTRUM REGARDING PATIENTS ENROLLED IN A (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2009. ADDITIONAL RECEIVED INDICATES THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672720 M2A 38MM MOD HEAD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R