BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT

    MDR report key: 4810481 · Received June 1, 2015

    Report

    Report Number
    1822565-2015-00781
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    March 3, 2014
    Report Date
    April 27, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRIMARY SURGICAL NOTES SUGGEST THAT THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE REVISION SURGICAL NOTES STATE THAT THE RIGHT TOTAL KNEE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY AND CHRONIC SYNOVITIS. AN EXCESSIVE AMOUNT OF SYNOVIUM AND SCAR TISSUES WERE REMOVED. THE FEMORAL COMPONENT WAS REMOVED WITHOUT DIFFICULTY WITH OSTEOTOMES, AND WITH VERY LITTLE TO NO SIGNIFICANT BONE LOSS. PER THE PACKAGE INSERT OF THE FEMORAL COMPONENT, PAIN AND LOOSENING OF THE PROSTHETIC KNEE COMPONENTS ARE KNOWN ADVERSE EFFECTS OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE FOUND. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATION. SURGICAL NOTES 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.

    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 PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352905 NEXGEN LPS-FLEX OPTION FEMORAL COMPONENT NJL NJL ZIMMER, INC. 61556905

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention