BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS - FLEX FEMORAL COMPONENT

    MDR report key: 3022444 · Received March 20, 2013

    Report

    Report Number
    1822565-2013-00505
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    April 25, 2010
    Report Date
    February 21, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. FIT AND ORIENTATION COULD NOT BE EVALUATED WITHOUT X-RAYS OR SURGICAL NOTES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVALUATION: MANUFACTURING DOCUMENTATION FOR THE FEMORAL AND PATELLAR COMPONENTS WAS REVIEWED AND INDICATES THAT THOSE DEVICES WERE MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. THE PART AND LOT NUMBERS OF THE OTHER COMPONENTS ARE UNK; THEREFORE, DEVICE HISTORY REVIEWS ARE NOT POSSIBLE FOR THOSE COMPONENTS. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OR PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, 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 WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116305 NEXGEN LPS - FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 60332969

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention NEXGEN ARTICULAR SURFACE: CATALOG #UNK, LOT #UNK| NEXGEN TIBIAL COMPONENT: CATALOG #UNK, LOT #UNK| (B)(4)| LOT #60434515 - MANUFACTURED BY ZIMMER (B)(4)| NEXGEN ALL POLY PATELLA: CATALOG #00597206535,