BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINN RT HNG KNEE FMRL BSHG

    MDR report key: 5920499 · Received September 1, 2016

    Report

    Report Number
    0001825034-2016-03412
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 2, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK910877
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03398 / 03412). PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    DURING A REVISION PROCEDURE, IT WAS DISCOVERED THE PACKAGE OF FEMORAL BUSHINGS CONTAINED TWO DIFFERENT SIZES. AS A RESULT, ONE OF THE BUSHINGS WAS TOO TIGHT ON THE AXLE. THE BUSHINGS WERE NOT USED TO COMPLETE THE PROCEDURE, AS THEY WERE NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573486 FINN RT HNG KNEE FMRL BSHG PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 167020

    Patients

    Seq Age Sex Outcome Treatment
    1