BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED OPTION TIBIAL COMPONENT

    MDR report key: 5029289 · Received August 25, 2015

    Report

    Report Number
    2648920-2015-00316
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    July 29, 2015
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATION OF THE FEMORAL COMPONENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG #00597206529, NEXGEN ALL POLY PATELLA, LOT #60382198. THE FOLLOWING PRODUCTS WERE MANUFACTURED BY ZIMMER INC. (B)(4): CATALOG #00576401552, NEXGEN LPS-FLEX GSF FEMORAL COMPONENT, LOT #60512005; CATALOG #00596403210, NEXGEN LPS-FLEX FXD ARTICULAR SURFACE, LOT #60533423. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING POSTOPERATIVE PAIN, SWELLING AND POSSIBLE ALLERGIC REACTION TO IMPLANTS. A REVISION HAS BEEN SCHEDULED FOR (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560482 NEXGEN STEMMED OPTION TIBIAL COMPONENT JWH JWH ZIMMER 60437143

    Patients

    Seq Age Sex Outcome Treatment
    1 Other