BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 3675139 · Received February 26, 2014

    Report

    Report Number
    2648920-2014-00036
    Event Type
    Injury
    Date Received
    February 26, 2014
    Report Date
    January 27, 2014
    Manufacturer
    ZIMMER
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS REPORTED IN ERROR ON INITIAL MDR #2648920-2016-00950 ON 26-JUL-2016.

    Additional Manufacturer Narrative · 1

    THE PRIMARY OPERATIVE NOTES STATE THAT WITH TRIAL COMPONENTS, GOOD MOTION, STABILITY, AND RANGE OF MOTION WERE ACHIEVED, AS WELL AS EXCELLENT PATELLA TRACKING. NO COMPLICATIONS WERE NOTED. SURGICAL NOTES DID NOT INDICATE ANY DETAILS RELATED TO THE REPORTED ALLERGENS. COMPOSITION OF THE PROSTHESES AND BONE CEMENT USED WERE REVIEWED TO ENSURE THAT ETHYLENEDIAMINE DIHYDROCHLORIDE (EDD) IS NOT INCLUDED. TWO SETS OF X-RAYS WERE PROVIDED. IMMEDIATE POST-OP X-RAYS APPEAR TO SHOW APPROPRIATELY ALIGNED COMPONENTS. AP VIEW X-RAY DATED (B)(6) 2014 APPEARS TO DEPICT THE ENTIRE KNEE JOINT INTERNALLY ROTATED, AND POSSIBLE LATERAL OVERHANG OF THE TIBIAL COMPONENT. HOWEVER, DARKER AREAS NOTED UNDERNEATH THE TIBIAL COMPONENT MAY BE ATTRIBUTED TO THE REPORTED DEMINERALIZATION. ML VIEW X-RAY DATED (B)(6) 2014 APPEARS TO SHOW SLIGHT GAP UNDER THE ANTERIOR FLANGE OF THE FEMORAL COMPONENT, AND POSSIBLE OVERHANG OF THE CONDYLE TOES POSTERIORLY. NO OTHER REPORTS OF ANY NATURE HAVE BEEN RECEIVED REGARDING THE REPORTED PART AND LOT NUMBER COMBINATIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE INTERNALLY MANUFACTURED COMPONENTS, AND NO DEVIATIONS RELATED TO THIS REPORTED EVENT WERE NOTED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING CONSIDERABLE SWELLING AND LOSS OF RANGE OF MOTION. IT IS ALSO NOTED THAT A RECENT X-RAY SHOWS DEMINERALIZATION AROUND THE TIBIA COMPONENT. TESTING HAS CONFIRMED THE PT HAS A CONTACT ALLERGY TO ETHYLENEDIAMINE DIHYDROCHLORIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117548 NEXGEN STEMMED TIBIAL COMPONENT PRECOAT JWH ZIMMER 62441038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG #00596001551, LOT #62389108,| MANUFACTURED BY ZIMMER (B)(4)