BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD 4MM

    MDR report key: 5741245 · Received June 22, 2016

    Report

    Report Number
    0001825034-2016-02210
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    May 19, 2016
    Report Date
    May 25, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DEVICE PRODUCT CODE - NI, EXPIRATION DATE - NI, DATE IMPLANTED - NI, MANUFACTURE DATE ¿ NI. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. ADDITIONAL EVENT FOR THIS PATIENT REPORTED ON MEDWATCH NUMBER 1825034-2016-02211.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - BIOMET M2A CUP, CATALOG#: US157860, LOT#: 790800; BIOMET FEMORAL STEM, CATALOG#: 11-103208, LOT#: 570490; BIOMET TAPER ADAPTER, CATALOG#: 139266, LOT#: 192980.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE DUE TO UNKNOWN REASONS. THE HEAD AND TAPER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THE HEAD AND TAPER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397838 M2A-MAGNUM MODULAR HEAD 4MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 147990

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R