BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2890768 · Received December 21, 2012

    Report

    Report Number
    1822565-2012-02609
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    June 27, 2005
    Report Date
    November 28, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEW OF SURGICAL REPORTS PROVIDED INDICATES PRIMARY SURGICAL TECHNIQUE WAS FOLLOWED. RESULT REPORTED FROM MANIPULATION WAS A STABLE RANGE OF MOTION. NO X-RAYS WERE RECEIVED, BUT THE MANIPULATION REPORT INDICATES A PROPER TOTAL KNEE REPLACEMENT. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT EXAMINATION UNDER ANESTHESIA WITH LYSIS OF ADHESIONS FOR HER LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER INC 60209103

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention NEXGEN LPS-FLEX ARTICULAR SURFACE:| MANUFACTURED BY ZIMMER (B)(4)| NEXGEN STEMMED TIBIAL COMPONENT:| NEXGEN ALL POLY PATELLA: CATALOG #00597206532| CATALOG #00596004012, LOT #60201529| NEXGEN STEM EXTENSION REPLACEMENT SCREW:| CATALOG #00598009000, LOT #60273730| CATALOG #00598004701, LOT #60233873| LOT #60258435