BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781320 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01599
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN CR FEMORAL COMPONENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MALPOSITION OF AN UNKNOWN FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT REVISION OF TOTAL KNEE DUE TO INSTABILITY DUE TO PCL DEFICIENCY AND ROTATION WAS MALROTATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT REVISION OF TOTAL KNEE DUE TO INSTABILITY DUE TO PCL DEFICIENCY AND ROTATION WAS MALROTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258930 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention