BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI LFIT MEDIAL FEMORAL COMP.

    MDR report key: 3057913 · Received April 15, 2013

    Report

    Report Number
    0002249697-2013-01316
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HRY
    PMA / PMN Number
    K911373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    BRAND NAME: UNI LFIT MEDIAL FEMORAL COMP. PRODUCT CODE: HRY. CATALOG #: 4010-007R-I. PMA/510(K) #: K911373. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FAILED UNI KNEE, LOOSE, POLY WEAR, CONVERSION TO TRIATHLON PRIMARY KNEE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FAILED UNI KNEE, LOOSE, POLY WEAR, CONVERSION TO TRIATHLON PRIMARY KNEE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160186 UNI LFIT MEDIAL FEMORAL COMP. IMPLANT HRY STRYKER ORTHOPAEDICS-MAHWAH K00K495

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention