BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -3MM NK

    MDR report key: 4191440 · Received October 21, 2014

    Report

    Report Number
    0001825034-2014-08270
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 11, 2014
    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 PATIENT AGE, EVENT DESCRIPTION, 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 (B)(4) REGARDING PATIENTS ENROLLED IN A (B)(4) STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. ADDITIONAL INFORMATION RECEIVED INDICATES THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM (B)(6) REGARDING PATIENTS ENROLLED IN (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. ADDITIONAL INFORMATION RECEIVED INDICATES THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669983 M2A 38MM MOD HD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R