BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINMTC ROT HINGE SHRT TIB BEAR

    MDR report key: 4081142 · Received September 11, 2014

    Report

    Report Number
    0002249697-2014-03447
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LGE
    PMA / PMN Number
    K992346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. PATIENT RETAINED DEVICE.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE AND EXPIRATION DATE CORRECTED. AN EVENT REGARDING A FRACTURE INVOLVING A KRH TIBIAL BEARING COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL NOT PERFORMED AS INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. THE CLINICAL CONSULTANT COMMENTED THAT IT IS NOT POSSIBLE TO ESTABLISH A ROOT CAUSE OF FAILURE BASED UPON THE CURRENT INFORMATION. DEVICE HISTORY REVIEW. ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING OF THE RIGHT KNEE. PATIENT HAS KRH HINGE. UPON EXPLORATION IT WAS DISCOVERED THAT THE POST GOING INTO THE BASEPLATE WAS FRACTURED. THE SURGEON REPLACED BUSHINGS, POLY, ROTATING COMPONENT, AXLE, AND BUMPER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING OF THE RIGHT KNEE. PATIENT HAS KRH HINGE. UPON EXPLORATION IT WAS DISCOVERED THAT THE POST GOING INTO THE BASEPLATE WAS FRACTURED. THE SURGEON REPLACED BUSHINGS, POLY, ROTATING COMPONENT, AXLE, AND BUMPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560436 KINMTC ROT HINGE SHRT TIB BEAR IMPLANT LGE STRYKER ORTHOPAEDICS-MAHWAH IDBD

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| O| R