BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA MOD TIB INSERT SML 11MM

    MDR report key: 2121391 · Received June 7, 2011

    Report

    Report Number
    2249697-2011-00842
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED: "REVISION RIGHT KNEE SURGEON DIAGNOSIS PATELLOFEMORAL PAIN AND POLYETHYLENE WEAR, PCA MODULAR TIBIAL BASEPLATE S2, DURACON FEMUR SMALL, SMALL 11 MM TIBIAL POLY ORIGINAL SURGERY (B)(6) 1994. OBVIOUS WEAR ON MEDIAL SIDE OF INSERT. INSERT REMOVED AND REPLACED WITH 19 MM INSERT AND PATELLA RESURFACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MOD TIB INSERT SML 11MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention