BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 4.5/5 BROAD CURV 12HO L229 TI

    MDR report key: 3142567 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02592
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RECEIVED ON 05/22/2013 FOR EVALUATION. INVESTIGATION COORDINATED BY SYNTHES EUROPE. REPORT RECEIVED INDICATES BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO DYNAMIC AXIAL BENDING AND TORSIONAL LOADS. CONSTANTLY ALTERNATING BENDING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE IMPLANT. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT AND INSTABILITY OF THE FRACTURE SITUATION (BRITTLE FRACTURE) MAY HAVE PLAYED A CERTAIN ROLE, TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT HAD A FRACTURE IN THE SHAFT OF THE FEMUR. THE SURGEON IMPLANTED THE BROAD CURVED PLATE (12 HOLES) ON AN UNKNOWN DATE. THE SURGEON BENT THE PLATE IN THE OPERATION AND LOCKED IT BY THE LOCKING SCREW. THE DOCTOR NOTED THE PATIENTS BONE CORTEX WAS GOOD, HOWEVER, THE BONE ITSELF WAS VERY BRITTLE AS THE FRACTURE HAPPENED BY A TWISTING OF THE BODY. THE OPERATION COMPLETED WITH NO PROBLEMS. AFTER 8 WEEKS NON WEIGHT BEARING, THE REHABILITATION STARTED. AFTER 3 MONTHS, THE SURGEON FOUND THE PLATE WAS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243792 LCP 4.5/5 BROAD CURV 12HO L229 TI HRS SYNTHES GMBH 8069175

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention