BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 5267867 · Received December 4, 2015

    Report

    Report Number
    1822565-2015-02565
    Event Type
    Injury
    Date Received
    December 4, 2015
    Report Date
    August 6, 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

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE THE LITERATURE AT THE FOLLOWING ADDRESS:HTTP://WWW.BJJ.BONEANDJOINT.ORG.UK/CONTENT/89-B/11/1457.LONG (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES IN SECTIONS. THE PART NUMBERS AND LOT NUMBERS ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AND A PRODUCT HISTORY SEARCH FOR RELATED COMPLAINTS COULD NOT BE CONDUCTED. NO RADIOGRAPHS WERE RECEIVED, THEREFORE THE ALLEGED OBSERVATION OF RADIOLUCENT LINES CANNOT BE CONFIRMED. THIS DEVICE IS USED FOR TREATMENT. REVIEW OF THE MANUSCRIPT FOUND THAT THE PATIENTS FOLLOWED A TRADITIONAL KOREAN LIFE STYLE, WHICH DEMANDED WEIGHT-BEARING HIGH-FLEXION ACTIVITIES IN DAILY LIFE. REVIEW OF THE SUMMARIZED SURGICAL TECHNIQUE SUGGEST THAT THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION, AND THAT THE BONE CEMENT WAS APPLIED AS PER THE SURGICAL TECHNIQUE. AS REPORTED PROGRESSIVE COMPLETE RADIOLUCENT LINES WERE OBSERVED BENEATH THE ANTERIOR FLANGES OF THE FEMORAL COMPONENTS ON LATERAL RADIOGRAPHS OF 12 TKRS AT A MEAN OF 32 MONTHS (30 TO 48) AFTER OPERATION. HOWEVER, THIS LOOSENING WAS NOT ASSOCIATED WITH OSTEOLYSIS. PER THE COMPONENTS PACKAGE INSERT, LOOSENING OF THE PROSTHETIC KNEE COMPONENTS IS A KNOWN ADVERSE EFFECT OF THIS PROCEDURE AND THE PATIENT SHOULD BE INSTRUCTED AGAINST EXCESSIVE PHYSICAL AND OCCUPATIONAL ACTIVITIES THAT CAN RESULT IN LOOSENING OF THE KNEE IMPLANT. THE REPEATED HIGH-FLEXION ACTIVITIES OF THE PATIENTS IS VERY LIKELY TO HAVE CONTRIBUTED TO THE LOOSENING OF THE FEMORAL COMPONENT AND THE PATIENT CONDITION IS CONSIDERED AS THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT TWELVE FEMURS WERE FOUND TO HAVE RADIOLUCENT LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799086 UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other