BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL LATERAL FEMUR PLATE TS AXSOS FOR LEFT FEMUR 10 HOLE / L238MM

    MDR report key: 4131154 · Received October 1, 2014

    Report

    Report Number
    0008031020-2014-00460
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 14, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE BROKEN AXOS DISTAL FEM PLATE FOR DISTAL LATERAL FEMUR PLATE TS AXSOS FOR LEFT FEMUR 10 HOLE / L238MM COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT RELATED ISSUE. THE PATIENT PRESENT A BMI SUPERIOR TO 30 (31) WHICH CORRESPOND TO AN OBESITY CLASS I. THIS CAN LEAD TO THE FAILURE OF THE REF#(B)(4). SEE CONTRAINDICATION, V15013 K NON ACTIVE IMPLANT IFU. NOTE: "CONTRAINDICATIONS OBESITY. AN OVERWEIGHT OR OBESE PATIENT CAN PRODUCE LOADS ON THE IMPLANT THAT CAN LEAD TO FAILURE OF THE FIXATION OF THE DEVICE OR TO FAILURE OF THE DEVICE ITSELF." (V15013 K NON ACTIVE IMPLANT IFU) [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    BROKEN AXOS DISTAL FEM PLATE.

    Description of Event or Problem · 1

    BROKEN AXOS DISTAL FEM PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612206 DISTAL LATERAL FEMUR PLATE TS AXSOS FOR LEFT FEMUR 10 HOLE / L238MM IMPLANT HRS STRYKER TRAUMA SELZACH Z33099

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention