BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH KNEE FEM S LFT

    MDR report key: 3023778 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01100
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TIBIAL IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TIBIAL IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    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. THE EVENT WAS CONFIRMED. MEDICAL REVIEW COMPLETED INDICATED THAT THE REPORTED DEVICE WAS SUBJECT TO CYCLIC LOADING RESULTING IN FATIGUE FRACTURE HOWEVER OPERATIVE REPORTS AND SUPPORTING MEDICAL DOCUMENTATION WAS NOT PROVIDED. MATERIAL ANALYSIS COMPLETED ON THE RETURNED DEVICE INDICATED THAT THE FEMORAL CONDYLE BROKE IN FATIGUE. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFECTS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A PROXIMAL TIBIAL IMPLANT AND IS HAVING PAIN IN THAT KNEE CURRENTLY. EXPLORATORY SURGERY IS SCHEDULED ON (B)(6). ADDITIONAL EVENT DESCRIPTION: IT WAS REPORTED THAT THE FEMORAL COMPONENT MRHK FLANGE FRACTURED. THE FEMORAL IMPLANT WAS REMOVED AND A GMRS DISTAL FEMUR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A PROXIMAL TIBIAL IMPLANT AND IS HAVING PAIN IN THAT KNEE CURRENTLY. EXPLORATORY SURGERY IS SCHEDULED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126150 MRH KNEE FEM S LFT IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH LKSLM-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention