BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIB BEARING COMP ROT/HIN KNEE

    MDR report key: 2503696 · Received March 21, 2012

    Report

    Report Number
    9610726-2012-00091
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LGE
    PMA / PMN Number
    K811630
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6475-3-940, LOT # TDAC210, DESCRIPTION: KRH STANDARD AXLE. CAT # 6485-2-460, LOT # TCPB233, DESCRIPTION: KRH DURATION BUSHING STANDARD. CAT # 6485-2-460, LOT # TCPB238, DESCRIPTION: KRH DURATION BUSHING STANDARD. CAT # 6485-4-100, LOT # TCPBA50, DESCRIPTION: KRH DURATION STANDARD BUMPER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ¿PT PRESENTED WITH INCREASED PAIN AFTER A FALL. THE PT SAID SHE FELT LIKE THINGS WERE LOOSE. WE REPLACED THE ABOVE REFERENCED PARTS. THE PARTS THAT WERE REMOVED WERE NOT EXCESSIVELY WORN. UPON INCISION, THERE WAS A LARGE EVACUATION OF A HEMATOMA. DR (B)(6) DECIDED TO REMOVE THE 10 YEAR OLD COMPONENTS REFERENCED ABOVE AND HE DID A SYNOVECTOMY. THERE WAS SOME OSTEOLYSIS NOTED ON THE MEDIAL PROXIMAL TIBIA. BOTH THE FEMORAL COMPONENT AND THE TIBIAL COMPONENT WERE EVALUATED AND WERE DEEMED TO BE STABLE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIB BEARING COMP ROT/HIN KNEE IMPLANT LGE STRYKER ORTHOPAEDICS LIMERICK NA KOGR

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention