BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 5514870 · Received March 21, 2016

    Report

    Report Number
    3007963827-2016-00014
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    February 25, 2016
    Manufacturer
    ZIMMER, BUILDING #2
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #00596403212, NEXGEN LPS-FLEX FIXED ARTICULAR SURFACE, LOT #62401606 - MANUFACTURED BY ZIMMER INC., (B)(4). CATALOG #00598003702, NEXGEN STEMMED PRECOAT TIBIAL COMPONENT, LOT #62772509 - MANUFACTURED BY ZIMMER (B)(4). CATALOG #00597206532, NEXGEN ALL-POLY PATELLA, LOT #62747844 - MANUFACTURED BY ZIMMER (B)(4). CATALOG #00598801215, NEXGEN STRAIGHT STEM EXTENSION, LOT #62746047 - MANUFACTURED BY ZIMMER (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO AMEND: IMPLANT DATE, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE? AND ADDITIONAL MFR NARRATIVE.

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. NO COMPATIBILITY ISSUES WERE NOTED. THE COMPLAINT HISTORY SEARCH PERFORMED INDIVIDUALLY FOR THE PART AND LOT COMBINATION FOR TIBIAL, ARTICULAR SURFACE, FEMORAL, PATELLA AND STEM COMPONENT FOUND NO OTHER COMPLAINTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN IN HER LEFT KNEE AND IS HAVING TROUBLE GETTING INTO A VEHICLE AND CLIMBING STAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169409 NEXGEN LPS-FLEX FEMORAL COMPONENT JWH JWH ZIMMER, BUILDING #2 62767672

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other