BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO COMPOSITE DISTAL FEMUR PLATE

    MDR report key: 10383121 · Received August 9, 2020

    Report

    Report Number
    9615128-2020-00010
    Event Type
    Injury
    Date Received
    August 9, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 9, 2020
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HRS
    UDI-DI
    07290109335247
    PMA / PMN Number
    K143496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE INVOLVED A COMMINUTED FRACTURE OF THE FEMUR IN A (B)(6)-YEAR OLD PATIENT WITH A KNEE PROTHESIS. EXAMINATION OF THE INVOLVED IMPLANT, AS WELL AS ITS PRODUCTION RECORDS, INDICATED IT WAS MANUFACTURED ACCORDING TO SPECIFICATION. X-RAYS PROVIDED TO THE COMPANY, REVEALED NONUNION OF THE FRACTURE. IMPORTANTLY, THE PLATE SUPPORTED THE FRACTURE FOR MORE THAN 7 MONTHS; IT FINALLY FAILED AT THE AREA OF BONE FRACTURE MOST PROBABLY DUE TO A COMBINATION OF FATIGUE AND EXCESSIVE BENDING LOAD. STUDIES SHOW THAT COMPLICATIONS FOLLOWING TREATMENT WITH DISTAL FEMUR PLATES, INCLUDING NONUNION AND IMPLANT FAILURE, ARE NOT INFREQUENT (1). ACCORDING TO HOFFMANN ET AL., HARDWARE FAILURE WAS RELATED TO NONUNION; ADDITIONALLY, FRACTURES PROXIMAL TO TOTAL KNEE ARTHROPLASTIES HAD A SIGNIFICANTLY GREATER RATE OF FAILED HARDWARE (2). THEIR STUDY DEMONSTRATED IMPLANT FAILURE RATES OF 9.9% AND NONUNION RATES OF 3.6%. HENDERSON CE ET AL, LOCKING PLATES FOR DISTAL FEMUR FRACTURES: IS THERE A PROBLEM WITH FRACTURE HEALING? JOURNAL OF ORTHOPAEDIC TRAUMA: FEBRUARY 2011 - VOLUME 25 - ISSUE - P S8-S14. HOFFMANN MF ET AL., CLINICAL OUTCOMES OF LOCKED PLATING OF DISTAL FEMORAL FRACTURES IN A RETROSPECTIVE COHORT. J ORTHOP SURG RES. 2013; 8: 43.

    Description of Event or Problem · 1

    A DISTAL FEMUR PLATE WAS IMPLANTED (IN (B)(6)), TO TREAT A PERIPROSTHETIC COMMINUTED FRACTURE IN A (B)(6)-YEAR OLD PATIENT. APPROXIMATELY 7.5 MONTHS AFTER IMPLANTATION, THE PLATE BROKE DURING A PHYSIOTHERAPY TREATMENT. THE PLATE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847414 PICCOLO COMPOSITE DISTAL FEMUR PLATE BONE PLATE HRS CARBOFIX ORTHOPEDICS LTD. Distal Femur Plate 91741 07290109335247

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention