BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HMRS DISTAL FEMUR LEFT 16OMM

    MDR report key: 3952532 · Received July 23, 2014

    Report

    Report Number
    0002249697-2014-02846
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    6367-1-216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE CORRECTED. 510K UPDATED AND IMPLANT DATE UPDATED. AN EVENT REGARDING LOOSENING OF THE CONNECTION OF THE FEMORAL COMPONENT INVOLVING AN HMRS DISTAL FEMUR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS RETURNED FOR EVALUATION. IT WAS VISUALLY UNREMARKABLE. THE DEVICE WAS DIMENSIONALLY AND FUNCTIONALLY ACCEPTABLE. MEDICAL EVALUATION WAS NOT POSSIBLE DUE TO INSUFFICIENT INFORMATION WAS PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW. ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT MEDICAL RECORDS WERE PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PRIMARY OPE DATE WAS NOT SPECIFIED AT THIS TIME. THE PATIENT UNDERWENT THE REPLACEMENT WITH HMRS DISTAL FEMUR COMPONENT. AT THE TIME WHEN HE STARTED WALKING IN THE POOL, GAP WAS CONFIRMED BETWEEN DISTAL FEMORAL COMPONENT AND ANCHOLAGE STEM. ON (B)(6) 2014, REVISION SURGERY WAS PERFORMED. ANCHOLAGE STEM WAS FIXED WITH THE BONE. THE LOOSENING OF THE CONNECTION OF FEMORAL COMPONENT AND ANCHOLAGE STEM WAS CONFIRMED. ONLY THE FEMORAL COMPONENT WAS REPLACED.

    Description of Event or Problem · 1

    PRIMARY OPE DATE WAS NOT SPECIFIED AT THIS TIME. THE PATIENT UNDERWENT THE REPLACEMENT WITH HMRS DISTAL FEMUR COMPONENT. AT THE TIME WHEN HE STARTED WALKING IN THE POOL, GAP WAS CONFIRMED BETWEEN DISTAL FEMORAL COMPONENT AND ANCHOLAGE STEM. ON (B)(6) 2014, REVISION SURGERY WAS PERFORMED. ANCHOLAGE STEM WAS FIXED WITH THE BONE. THE LOOSENING OF THE CONNECTION OF FEMORAL COMPONENT AND ANCHOLAGE STEM WAS CONFIRMED. ONLY THE FEMORAL COMPONENT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430991 HMRS DISTAL FEMUR LEFT 16OMM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH S797J

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention