BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A HIP

    MDR report key: 3181699 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02133
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE EXPLANTED - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BILATERAL PATIENT ENROLLED IN THE MOM 480 CLINICAL STUDY, UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON SEPTEMBER 1, 2010 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. A SUBSEQUENT REVISION OF THE LEFT HIP WAS PERFORMED ON AN UNKNOWN DATE DUE TO CUP LOOSENING AND RADIOLUCENCY. THE CUP WAS REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282054 UNKNOWN M2A HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R