BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ORTHOPEDICS

    MDR report key: 3204003 · Received June 27, 2013

    Report

    Report Number
    MW5030726
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER ORTHOPEDICS
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LEFT KNEE HARDWARE REMOVAL SECONDARY TO PAIN, SWELLING, LOCKING, CATCHING AND POPPING OF THE KNEE. REMOVAL OF THE HARDWARE WAS NECESSARY TO "PREVENT PERMANENT IMPAIRMENT OF THE BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE." OPERATIVE REPORT STATES LEFT KNEE REVISION TOTAL KNEE REPLACEMENT WITH EXCISION OF A LARGE CEMENT FRAGMENT. SIGNIFICANT SCAR TISSUE WAS REMOVED. POLYETHYLENE WAS REMOVED ALSO. THE 13MM X 8MM CR POLY WAS INSERTED TO REPLACE THE EXPLANTED 11MM POLY. REPLACEMENT WAS A STRYKER ORTHO TIBIAL BEARING INSERT. EXPLANT WAS SENT PER REQUEST OF SURGEON TO (B)(6) ORTHOPEDIC LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293150 STRYKER ORTHOPEDICS TIBIAL BEARING INSERT 11MM HSH STRYKER ORTHOPEDICS 5530P811 1CH091
    293293 STRYKER ORHTOPEDICS CEMENT BONE W/TROBRAMYCIN LOD STRYKER ORHTOPEDICS 61979001 MGT070

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR