BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 16 HOLE / L343MM

    MDR report key: 4401454 · Received January 9, 2015

    Report

    Report Number
    0008031020-2015-00020
    Event Type
    Injury
    Date Received
    January 9, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 16, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K123964
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF BREAKAGE AFTER SURGERY FOR DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 16 HOLE / L343MM COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT RELATED ISSUE. ACCORDING IWT INSTITUT (INSTITUT FÜR WERKSTOFFTECHNOLOGIE AG) "FATIGUE IS THE FRACTURE MECHANISM OF THE PLATE" (ALTERNATING BENDING LOAD) "THIS ALTERNATING BENDING LOAD COULD BE CAUSED BY NORMAL FORCES, CREATED BY WALKING" (IWT REPORT NO. (B)(4)). IT CAN BE STATED THAT AN OVERLOADING OF THE BONE PLATE BY THE APPLIED DYNAMIC FORCES WAS THE MOST PROBABLE CAUSE. NO INDICATIONS COULD BE FOUND, THAT OTHER FACTORS, SUCH AS THOSE EXPECTED IN IWT REPORT NO. (B)(4), WOULD HAVE FAVOURED CRACK INITIATION." (IWT REPORT NO. (B)(4)). ADDITIONALLY PATIENTS' (B)(6) (OBESITY) 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). REPRESENTATIVE "REPORTED THAT THERE WAS NONUNION." ((B)(6) 2015 4:51 PM) IN THIS CASE "DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING" (V15013 K NON ACTIVE IMPLANT IFU). MORE GENERALLY "THESE DEVICES ARE INTENDED ONLY TO ASSIST HEALING AND ARE NOT INTENDED TO REPLACE NORMAL BONE STRUCTURES." (V15013 K NON ACTIVE IMPLANT IFU). SEE BELOW FOR MORE DETAILS. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED ON RIGHT KNEE DUE TO PAIN AND BROKEN PLATE. ADDITIONAL INFORMATION RECEIVED, REP REPORTED THAT THERE WAS NONUNION. PATIENT WAS REVISED BY IMPLANTING A ROD.

    Description of Event or Problem · 1

    PATIENT WAS REVISED ON RIGHT KNEE DUE TO PAIN AND BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23792 DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 16 HOLE / L343MM PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH R17429

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention