BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT

    MDR report key: 3983023 · Received August 6, 2014

    Report

    Report Number
    2520274-2014-12993
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES BETTLACH
    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

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT IS FOR THE FEMORAL PLATE, PART AND LOT NUMBER UNKNOWN. THE PART NUMBER AND LOT NUMBER REPORTED, PART NUMBER 442.254 AND LOT NUMBER 2127936, COULD NOT BE LOCATED IN THE SYNTHES PRODUCT DATA BASES EVENT DATE WAS REPORTED AS (B)(6) 2014 HOWEVER IT IS NOT KNOWN IF THIS DATE WAS FOR THE REVISION SURGERY OR THE DATE THE PLATE MAY HAVE BROKEN WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS 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

    (B)(4). DEVICE WAS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY WAS PERFORMED FOR A BROKEN FEMORAL PLATE THAT WAS IMPLANTED ON (B)(6) 2013. NO OTHER DETAILS OF THIS EVENT HAVE BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIALLY THE PATIENT WAS DIAGNOSED WITH A SPIRODIAL DIAPHYSEAL FRACTURE OF THE FEMUR BETWEEN A NON-SYNTHES NAIL AND KNEE PROSTHESIS WITH HEMARTHROSIS. ON (B)(6) 2013 THE PATIENT UNDERWENT A REDUCTION AND OSTEOSYNTHESIS WITH REMOVAL OF DISTAL SCREW ON THE NON-SYNTHES NAIL, OSTEOSYNTHESES BY A NINE-HOLE SYNTHES LOCKING COMPRESSION PLATE AND THIRTEEN SYNTHES SCREWS. THE POST-OPERATIVE RECOMMENDATION WAS SUPPORT WAS FORBIDDEN FOR THREE MONTHS. FOUR TO FIVE MONTHS LATER THE PATIENT WAS DIAGNOSED WITH DIAPHYSEAL ITERATIVE FRACTURE OF THE RIGHT FEMUR UNDER THE NON-SYNTHES NAIL AND ABOVE THE KNEE PROSTHESIS AND A FRACTURE OF THE SYNTHES PLATE. THE BROKEN PLATE WAS REMOVED AND THE PATIENT WAS REVISED WITH ILIAC BONE GRAFT AND NEW OSTEOSYNTHESIS BY AN ELEVEN-HOLE SYNTHES LOCKING COMPRESSION PLATE. THE POST-OPERATIVE RECOMMENDATION WAS IMMOBILIZATION BY SPLINT IN EXTENSION AND IMMEDIATE RE-EDUCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461055 TI LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT PLATE, FIXATION, BONE HRS SYNTHES BETTLACH 2127936

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention