BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2925099 · Received January 17, 2013

    Report

    Report Number
    1822565-2013-00115
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    August 21, 2008
    Report Date
    December 19, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL NOTES WERE PROVIDED FOR THE PRIMARY SURGERY AND FOR THE MANIPULATION PROCEDURE. IT WAS NOTED IN THE PRIMARY PROCEDURE THAT "THE KNEE WAS PUT THROUGH A FULL RANGE OF MOTION, WAS STABLE IN FLEXION AND EXTENSION, CAME TO FULL EXTENSION, AND THE PATELLA TRACKED NORMALLY." NEED FOR MANIPULATION IS A KNOWN RISK OF KNEE SURGERY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: 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. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT MANIPULATION UNDER ANESTHESIA WHICH INSERTION OF INTRA-ARTICULAR PAIN PUMP CATHETER DUE TO DECREASED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25520 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 60232938

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention LOT #60902617, MANUFACTURED BY ZIMMER BV,| NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE:| NEXGEN ALL POLY PATELLA: CATALOG #00597206532,| NEXGEN MIS DROP DOWN STEM PLUG:| CATALOG #00595006700, LOT #60411832| CATALOG #00595003701, LOT #60881695| CATALOG: #00596203012, LOT #60246381| PONCE, PUERTO RICO| NEXGEN MIS STEMMED TIBIAL COMPONENT: