BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESS ANCHOR PLUG

    MDR report key: 2171279 · Received July 15, 2011

    Report

    Report Number
    MW5021386
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    February 9, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PT UNDERWENT REVISION OF FEMORAL COMPONENT OF MEGAPROSTHETIC FEMUR RECONSTRUCTION OF THE KNEE. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2005. XRAYS ON (B)(6) 2011 INDICATED THAT A SMALL CALIBER METALLIC COMPONENT ADJACENT TO THE PROXIMAL FEMORAL COMPONENT WITH TRAVERSING SCREWS HAD FRACTURED SINCE A COMPARATIVE RADIOLOGY FILM OF (B)(6) 2010. THE REVISION WAS DONE IN TWO STAGES AS AN INCORRECT ADAPTER WAS PROVIDED ON (B)(6) AND THE CORRECT ONE HAD TO BE RE-ORDERED. THE CAUSE OF THE METALLIC COMPONENT FRACTURE IS UNK. MFR WAS NOTIFIED OF FINDINGS ON (B)(6) 2011. FRACTURED COMPONENT WHICH WAS RETAINED IN THE RESECTED BONE, IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESS ANCHOR PLUG COMPRESS ANCHOR PLUG MBI BIOMET ORTHOPEDICS 582000

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR