BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4221275 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14279
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LC-DCP 4.5MM PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ¿SALVAGE OF INFECTED INTRAMEDULLARY KNEE ARTHRODESIS WITH VASCULARIZED FREE FIBULA AND STAGED FIXATION¿ (2014), CAVADAS. P.C., LORCA-GARCIA , C., PEREZ-GARCIA, A., ROMERO, F.C., AND THIONE, A. INJURY, INTERNATIONAL JOURNAL OF CARE OF THE INJURED, JINJ 5797; NO. OF PAGES 4. FROM 2008 TO 2012 FIVE PATIENTS (FOUR MEN AND ONE WOMAN) WERE TREATED FOR INFECTED AND LOOSE INTRAMEDULLARY BRIDGE ARTHRODESIS OF THE KNEE. AGE RANGED FROM 39 TO 71 YEARS (MEAN 57 YEARS). THE INDICATION FOR KNEE FUSION WAS INFECTED TOTAL KNEE ARTHROPLASTY IN ALL FIVE CASES. THE NUMBER OF SURGICAL PROCEDURES PRIOR TO ATTEMPT AT INTRAMEDULLARY ARTHRODESIS WAS 7¿15 (MEAN 10 PROCEDURES), WITH VARIOUS LONG-TERM SYSTEMIC ANTIBIOTIC REGIMES.AS PART OF STAGE ONE, A LONG DOUBLE-FRAME EXTERNAL FIXATOR WAS PLACED BETWEEN FEMUR AND TIBIA FOR TEMPORARY SKELETAL STABILIZATION (SYNTHES, (B)(4)). SUBSEQUENTLY, AFTER ADDITIONAL PLANNED TREATMENTS, THE EXTERNAL FIXATION WAS REMOVED AND RIGID INTERNAL FIXATION WAS PERFORMED WITH A LONG LIMITED CONTACT-DYNAMIC COMPRESSION PLATE (LC-DCP) 4.5 MM PLATE (SYNTHES, (B)(4)) PLACED LATERALLY WITH SCREWS IN THE FEMUR AND TIBIA, WITHOUT ADDITIONAL SCREWS IN THE FIBULA. THERE WAS NO MORTALITY ASSOCIATED TO THE TREATMENT PROTOCOL. THERE WERE NO SEPTIC COMPLICATIONS AFTER THE FIRST AND SECOND STAGES. A (B)(6) MALE (CASE 3) DEVELOPED DEEP INFECTION AFTER THE THIRD STAGE, RESPONSIVE TO LOCAL DRAINAGE AND CULTURE-GUIDED ANTIBIOTIC SUPPRESSION, WITHOUT NEGATIVE IMPACT IN BONE HEALING. BOTH PATIENTS UNDERWENT PLATE REMOVAL AFTER RADIOLOGICAL BONE CONSOLIDATION. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LC-DCP 4.5MM PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701129 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention