BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LCCK FEMORAL COMPONENT

    MDR report key: 5274352 · Received December 8, 2015

    Report

    Report Number
    1822565-2015-02597
    Event Type
    Injury
    Date Received
    December 8, 2015
    Report Date
    November 10, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THESE DEVICES ARE USED FOR TREATMENT SURGICAL NOTES WERE NOT PROVIDED. IT WAS REPORTED THAT THE KNEES WITH THE 9 TIBIAL AND 9 FEMORAL COMPONENTS THAT HAD A RADIOLUCENT LINE GREATER THAN 2MM HAD AN AORI TYPE F2B BONE DEFECT. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. SINCE PART AND LOT NUMBERS ARE UNKNOWN, A PRODUCT HISTORY SEARCH COULD NOT BE PERFORMED AND COMPATIBILITY COULD NOT BE VERIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE COMPLAINT MAY BE REVISED UPON RETURN OF X-RAYS AND/OR PRODUCT OR FURTHER INFORMATION

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE THE LITERATURE AT THE FOLLOWING ADDRESS: HTTP://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S0883540315002983. (B)(4). OTHER DEVICE USED: CATALOG #UNK, UNKNOWN LCCK TIBIAL COMPONENT, LOT #UNK. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT TWENTY-SIX FEMURS WERE FOUND TO HAVE RADIOLUCENT LINES GREATER THAN 1MM AND NINE WERE FOUND TO HAVE RADIOLUCENT LINES LESS THAN 2MM. NINE TIBIAS WERE FOUND TO HAVE RADIOLUCENT LINES GREATER THAN 2MM AND 11 WERE FOUND TO HAVE INCOMPLETE RADIOLUCENT LINES LESS THAN 1MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805802 UNKNOWN LCCK FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention