BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS FEX ARTICULAR SURFACE

    MDR report key: 6015451 · Received October 10, 2016

    Report

    Report Number
    0001822565-2016-03422
    Event Type
    Injury
    Date Received
    October 10, 2016
    Report Date
    March 9, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    Z-2412-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION SINCE THE DEVICE REMAINS IMPLANTED IN THE PATIENT; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT AND ARTICULAR SURFACE WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THE DEVICE HISTORY RECORDS FOR THE BONE CEMENT WERE PREVIOUSLY REVIEWED FOR DEVIATIONS FOR AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THE KNEE COMPONENT COMPATIBILITY MATRIX WAS REVIEWED AND IDENTIFIED THAT ALL THE COMPONENTS WERE COMPATIBLE. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR THE PRODUCT PART AND LOT COMBINATION OF THE TIBIAL COMPONENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENT WAS IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. HOWEVER, BASED ON THE PRODUCT LIST, THIS DEVICE WAS IMPLANTED ALONG WITH A DROP-DOWN STEM AND CEMENTED AS ADVISED IN THE REVISED SURGICAL TECHNIQUE ISSUED FROM THE INVESTIGATION AND SENT TO THE FIELD ON MAY 13, 2010. PER THE PACKAGE INSERT OF THE TIBIAL COMPONENT, LOOSENING IS A KNOWN POTENTIAL ADVERSE EFFECT OF THE TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING A FEELING OF LOOSENING AND HER KNEE BUCKLES WHEN STANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666440 NEXGEN LPS FEX ARTICULAR SURFACE KNEE PROTHESIS JWH ZIMMER, INC. 61218867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other