BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2860166 · Received November 21, 2012

    Report

    Report Number
    1822565-2012-02403
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE DAMAGE IS LIKELY TO PARTICLES OF BONE CEMENT OR ANOTHER HARD SUBSTANCE TRAPPED BETWEEN THE ARTICULAR SURFACE AND THE FEMORAL COMPONENT DURING THE TRIAL RANGE OF MOTION. THE SURGICAL TECHNIQUE INSTRUCTS TO REMOVE EXCESS CEMENT AND WAIT FOR THE CEMENT TO COMPLETELY CURE BEFORE INSERTING THE ARTICULAR SURFACE. IT CAN BE CONCLUDED THAT THE DEVICE WAS LIKELY DAMAGED DURING THE TRIAL RANGE OF MOTION. EVALUATION CODES: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. DIMENSIONAL ANALYSIS SHOWS THE DEVICE TO BE CONFORMING TO SPECIFICATIONS. VISUAL EXAMINATION SHOWS GOUGES AND SCRATCHING ON THE ARTICULAR SURFACE BUT DOES NOT APPEAR TO BE PITTING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE POLY WAS IMPLANTED. THE DOCTOR WENT THROUGH RANGE OF MOTION, LOOKED AT POLY AND NOTICED PITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 61709899

    Patients

    Seq Age Sex Outcome Treatment
    1