BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 6258495 · Received January 17, 2017

    Report

    Report Number
    0001822565-2017-00255
    Event Type
    Injury
    Date Received
    January 17, 2017
    Report Date
    May 18, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK991581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMMER NEXGEN TIBIAL PLATE COMPONENT CATALOG #: 00-5980-047-02 LOT #: NI, ZIMMER NEXGEN PATELLA CATALOG #: 00-5972-065-32 LOT #: NI, ZIMMER NEXGEN FEMORAL COMPONENT CATALOG #: 00-5990-015-02 LOT #: NI. THIS IS REPORT 2 OF 2 FOR THIS PATIENT. SEE ALSO 0001822565-2016-02037-1. THE LOT NUMBERS ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THESE DEVICES ARE 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. REVIEW OF THE IMPLANTED DEVICES IDENTIFIED NO COMPATIBILITY ISSUES. PER THE CURRENT NEXGEN CR-FLEX AND LPS-FLEX KNEE PACKAGE INSERT AT THE TIME OF THE PRIMARY SURGERY, POOR RANGE OF MOTION AND PAIN ARE KNOWN RISKS OF THIS PROCEDURE. 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, SWELLING, A CLICKING NOISE, AND LOSS OF RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38268 NEXGEN LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other