BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NK II SINTERLOCK FEMORAL COMPONENT

    MDR report key: 2925017 · Received January 17, 2013

    Report

    Report Number
    1822565-2013-00106
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    August 23, 2011
    Report Date
    December 18, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT ARTHROSCOPIC PROCEDURE DUE TO PAIN AND EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25626 NK II SINTERLOCK FEMORAL COMPONENT KNEE PROSTHESIS HSA ZIMMER, INC. 60903340

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention NATURAL-KNEE II ROTATING PLATFORM ULTRACONGRUENT| INSERT, CATALOG #630809310, LOT #60937569| BASEPLATE, CATALOG #630802301, LOT #07888157| NATURAL-KNEE II RORATING PLATFORM POROUS TIBIAL