BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3790307 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11092
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 16, 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

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. TAKEUCHI, R., ISHIKAWA, H., KUMAGAI, K., YAMAGUCHI, Y., CHIBA, N., AKAMATSU, Y., & SAITO, T. (2012). FRACTURES AROUND THE LATERAL CORTICAL HINGE AFTER A MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY: A NEW CLASSIFICATION OF LATERAL HINGE FRACTURE. THIS REPORT IS FOR AN UNKNOWN PLATE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. TAKEUCHI, R., ISHIKAWA, H., KUMAGAI, K., YAMAGUCHI, Y., CHIBA, N., AKAMATSU, Y., & SAITO, T. (2012). FRACTURES AROUND THE LATERAL CORTICAL HINGE AFTER A MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY: A NEW CLASSIFICATION OF LATERAL HINGE FRACTURE. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE FREQUENCY OF LATERAL HINGE FRACTURES AFTER OPENING-WEDGE HIGH TIBIAL OSTEOTOMY AND INVESTIGATE THE PATTERNS OF FRACTURE AND THEIR CLINICAL OUTCOME. FROM 2003 UNTIL 2008 THERE WERE 104 KNEES ANALYZED IN 93 PATIENTS WITH A MEAN AGE OF 68 PLUS OR MINUS 7 YEARS. OF THE KNEES, 74 WERE DIAGNOSED AS HAVING PRIMARY OSTEOARTHRITIS AND 30 WITH OSTEONECROSIS. THE MEAN FOLLOW-UP PERIOD WAS 41 MONTHS. LATERAL HINGE FRACTURES WERE CLASSIFIED AS FOLLOWS: TYPE I, THE FRACTURE REACHES JUST PROXIMAL TO OR WITHIN THE TIBIOFIBULAR JOINT; TYPE II, THE FRACTURE REACHES THE DISTAL PORTION OF THE PROXIMAL TIBIOFIBULAR JOINT; AND TYPE III, A LATERAL PLATEAU FRACTURE. A STANDARD POSTOPERATIVE REHABILITATION PROTOCOL WAS USED FOR TYPE I FRACTURES, 3 OF 5 PATIENTS WITH TYPE II FRACTURES WERE TREATED WITH NON-WEIGHT BEARING, AND TYPE III FRACTURES WERE TREATED WITH NON-WEIGHT BEARING UNTIL VISIBLE CALLUS FORMATION. LATERAL CORTEX FRACTURES WERE OBSERVED IN 26 KNEES: 19 TYPE I, 5 TYPE II, AND 2 TYPE III. IN THE TYPE II FRACTURE GROUP, 2 OF 5 PATIENTS WERE JUDGED TO HAVE A DELAYED BONE UNION. THERE WERE 2 CASES OF INFECTION, 1 DEEP AND 1 SUPERFICIAL. THERE WAS 1 CASE OF TRAUMATIC NEUROMA BUT NO INSTANCES OF IMPLANT FAILURE, NONUNION, OR DEEP VEIN THROMBOSIS AMONG OUR PATIENT COHORT. THE PATIENT WITH THE SUPERFICIAL INFECTION WAS A 74 YEAR OLD FEMALE AND THE INFECTION WAS OF THE SUBCUTANEOUS TISSUE THAT OCCURRED 2 MONTHS AFTER THE PROCEDURE. THE PLATE AND SCREWS WERE REMOVED. IN THE DEEP INFECTION CASE, THERE WERE SERIOUS COMPLICATIONS INCLUDING SEVERE LIVER CIRRHOSIS AND ANGINA PECTORIS. THE PLATE AND BONE SUBSTITUTES WERE REMOVED. HIGH TIBIAL OSTEOTOMY PATIENTS TREATED WITH A COMBINATION OF TOMOFIX (SYNTHES, (B)(4)) AND BONE SUBSTITUTE WERE ABLE TO WALK WITH FULL WEIGHT BEARING 2 WEEKS AFTER SURGERY. NO COMPLICATIONS WERE SEEN IN 19 PATIENTS WITH TYPE I FRACTURES. OF 5 PATIENTS WITH TYPE II FRACTURES, 2 HAD DELAYED UNIONS WITH A CORRECTION LOSS OF 3° AND 7°, RESPECTIVELY. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS REPORT IS FOR AN UNKNOWN PLATE. 1 OF 4 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266878 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention