BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 5267574 · Received December 4, 2015

    Report

    Report Number
    1822565-2015-02567
    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). OTHER DEVICE USED: CATALOG #UNK, UNKNOWN NEXGEN ARTICULAR SURFACE, LOT #UNK THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. INSUFFICIENT INFORMATION PROVIDED TO ENABLE A DEVICE HISTORY RECORD REVIEW. THESE DEVICES ARE USED FOR TREATMENT. A PRODUCT HISTORY SEARCH COULD NOT BE PERFORMED BECAUSE OF THE LACK OF INFORMATION REGARDING THE DEVICES RELATED TO THE EVENT. REVIEW OF THE MANUSCRIPT FOUND THAT THE PATIENT 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 RADIOLUCENT LINES WERE OBSERVED BENEATH THE ANTERIOR FLANGES OF THE FEMORAL COMPONENTS ON LATERAL RADIOGRAPHS AND THIS LOOSENING WAS NOT ASSOCIATED WITH OSTEOLYSIS. THE LOOSE FEMORAL COMPONENT WAS EASILY REMOVED BY HAND FROM ITS CEMENT MANTLE, INDICATING LOOSENING AT THE CEMENT-METAL INTERFACE. 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 ONE KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE ARTICULAR SURFACE WAS EXPLANTED DURING THE REVISION SURGERY AND IDENTIFIED TO HAVE PITTING AND DELAMINATION PLUS ROTATIONAL AND BURNISHING MARKS ON THE INFERIOR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797806 UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention