BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA MTK TIB/INS SMALL 7 LEFT OBSOLETE PRODUCT NO

    MDR report key: 2171329 · Received July 15, 2011

    Report

    Report Number
    2249697-2011-01074
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K864632
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME PATIENT / EVENT AS MFR # 2249697-2011-01073. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATELLA BUTTON WAS LOOSE IN JOINT SPACE. CURRENT IMPLANTS UNKNOWN SO REPLACEMENT INSERTS UNAVAILABLE. WE NEEDED TO THEN REMOVE ALL COMPONENTS AND REPLACE WITH TRIATHLON TS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MTK TIB/INS SMALL 7 LEFT OBSOLETE PRODUCT NO IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention