BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-RIGHT

    MDR report key: 4143485 · Received October 6, 2014

    Report

    Report Number
    3009450884-2014-10073
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    PK062564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. ORIGINAL IMPLANT WAS ON AN UNKNOWN DATE IN (B)(6) 2013. MANUFACTURING EVALUATION: BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES OF THE PLATE, IT CAN BE CONCLUDED THAT THE IMPLANT WAS SUBJECTED TO DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING BENDING LOADS / LOAD CYCLES (DURING WALKING) LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO FATIGUE-FORCED FRACTURE OF THE PLATE. THE PLATE COULD NOT RESIST THE APPLIED FORCE, WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS THE SECOND REVISION OF THE SURGERY. THIS PATIENT ORIGINALLY HAD A PERIPROSTHETIC FRACTURE ON AN UNKNOWN DATE IN (B)(6) 2013. THE FIRST REVISION SURGERY WAS NON SYNTHES PLATE, AFTER THE IMPLANT FAILURE THE PATIENT WAS TREATED FOR A SECOND REVISION. A REFRESH OF THE TWO BONE ENDS AND RESECTION OF BOTH SIDES ON THE BONE WAS DONE AND A LITTLE VALGUS POSITION WAS LEFT. THE SECOND REVISION WAS COMPLETED WITH A NON SYNTHES PLATES ON THE VENTRAL SIDE AND A DYNAMIC COMPRESSION PLATE WITH A LESS INVASIVE STABILIZATION SYSTEM FOR DISTAL FEMUR. A SYNTHETIC BONE GRAFT WAS ALSO USED. THE PLATE BROKE ON AN UNKNOWN DATE IN (B)(6) 2014. IT WAS ALSO REPORTED THAT PER AN INTERNAL REVIEW BY THE MEDICAL DIRECTOR; A PERIPROSTHETIC FRACTURE WAS DETERMINE BY THE X-RAY IMAGES. PER ADDITIONAL INFORMATION RECEIVED; THERE WAS PLATE BROKEN AND THERE WAS IS A SCREW THAT IS STUCK IN THE PLATE. THIS REPORT IS 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622330 TI LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-RIGHT PLATE,FIXATION,BONE HRS SYNTHES GRENCHEN 8468654

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention