BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MILLER-GALANTE KNEE IMPLANT

    MDR report key: 4941931 · Received July 23, 2015

    Report

    Report Number
    1822565-2015-01289
    Event Type
    Injury
    Date Received
    July 23, 2015
    Report Date
    June 25, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007/S00402-008-0670-2. IT WAS REPORTED IN A JOURNAL ARTICLE THAT THIRTEEN KNEES WERE IDENTIFIED TO HAVE VALGUS MALALIGNMENT GREATER THAN 8 DEGREES. THE JOURNAL ARTICLE INDICATES THAT ALL PATIENTS WERE IMPLANTED WITH A MILLER-GALANTE II UNICONDYLAR PROSTHESIS. THE PART AND LOT NUMBERS ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THESE DEVICES ARE USED FOR TREATMENT OF PATIENTS. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. OPERATIVE NOTES FOR PRIMARY AND REVISION SURGERIES WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    VALGUS MALALIGNMENT (GREATER THAN 8 DEGREES) WAS IDENTIFIED IN THIRTEEN KNEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480611 UNKNOWN MILLER-GALANTE KNEE IMPLANT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other