BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 4.5/5 BROAD CURV 14HO L265 SST

    MDR report key: 3123411 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02329
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 15, 2010
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE INVESTIGATION CARRIED OUT REVEALED THAT THE PLATE BROKE THROUGH THE SEVENTH DISTAL PLATE HOLE, NOT OCCUPIED BY A SCREW. THE DISTAL FRACTURE SURFACES OF THE PLATE WERE EXAMINED USING THE SCANNING ELECTRON MICROSCOPE AND THE INITIAL FRACTURE AREA, THE FRACTURE BEHAVIOR AND THE FINAL FRACTURE ZONE WERE IDENTIFIED. THE CRACK INITIATION STARTED AT THE UPPER SIDE OF THE PLATE HOLE AND RAN INTO THE MATERIAL. A PATTERN OF RIPPLES OR FATIGUE STRIATIONS WAS OBSERVED AT THE CRACK PROPAGATION ZONES AND RAN ALMOST OVER THE ENTIRE SURFACES. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT. THESE OBSERVED STRIATIONS ALONG WITH A VERY SMALL AREA WITH A DUCTILE ALVEOLATED BREAK STRUCTURE ARE CLEAR INDICATIONS OF A FATIGUE PROCESS. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION ¿ THE COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION AND THE CAUSE OF COMPLAINT IS CONSIDERED TO BE A RESULT OF THE CONDITION OF USE AS THE PLATE FRACTURE SURFACES SHOW FATIGUE STRIATIONS WHICH IS AN INDICATION OF A SLOWLY PROGRESSING FATIGUE FAILURE. FATIGUE FRACTURE IS TYPICALLY A RESULT OF STRESS AND WEAR ON THE DEVICE AS CAUSED BY CONDITION OF USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE BROKE UP IN SITU. THE PATIENT WAS TREATED WITH A FIXED LOCKING COMPRESSION PLATE, LCP FOR A FRACTURE OF THE DIAPHYSIS OF THE RIGHT FEMUR UNDER A CERAFIT TYPE SEALED HIP PROSTHESIS. THREE MONTHS POST-OP, THE PLATE BROKE AND THE PATIENT WAS REVISED. THE BROKEN PLATE WAS REMOVED AND REPLACED WITH ANOTHER LOCKING PLATE AND GRAFT DECORTICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224346 LCP 4.5/5 BROAD CURV 14HO L265 SST KTT SYNTHES GMBH 2523862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention