BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3923630 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12462
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. JUNG W-H, ET ALL, SECOND-LOOK ARTHROSCOPIC ASSESSMENT OF CARTILAGE REGENERATION AFTER MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY, ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, VOL. 30 NO.1 (JANUARY),2014:PP.72-79. THIS REPORT IS FOR AN UNKNOWN TOMOFIX PLATE. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.(B)(4).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: "SECOND-LOOK ARTHROSCOPIC ASSESSMENT OF CARTILAGE REGENERATION AFTER MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY". THE PURPOSES OF THIS STUDY WERE TO EVALUATE REGENERATION OF THE ARTICULAR CARTILAGE AFTER MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY FOR KNEES WITH MEDIAL-COMPARTMENT OSTEOARTHRITIS AND TO ASSESS THE CLINICAL OUTCOME AND CARTILAGE REGENERATION ACCORDING TO THE POSTOPERATIVE LIMB ALIGNMENT AT 2 YEARS POSTOPERATIVELY. THIS STUDY WAS A RETROSPECTIVE, NONRANDOMIZED, SEQUENTIAL REVIEW. BETWEEN JANUARY 2009 AND JANUARY 2010, 182 PATIENTS UNDERWENT HTO FOR MEDIAL COMPARTMENT OSTEOARTHRITIS OF THE KNEE. OF THE 182 PATIENTS, 23 WERE LOST TO FOLLOW-UP. WE PERFORMED FOLLOW-UP EVALUATIONS IN 159 CASES. ALL OF THESE PATIENTS UNDERWENT SECOND-LOOK ARTHROSCOPY DURING PLATE AND SCREW REMOVAL. POSTOPERATIVE COMPLICATIONS WERE ANALYZED RETROSPECTIVELY BY USE OF PATIENT CHARTS AND WERE DEFINED AS NONUNION, CORRECTION FAILURE (REVARIZATION OR OVERCORRECTION), AND INFECTION. TOMOFIX PLATE (SYNTHES, (B)(4)). A POROUS B-TRICALCIUM PHOSPHATE WEDGE (SEMICIRCULAR CHRONOS; SYNTHES) WAS INSERTED IN THE OSTEOTOMY GAP. THE TOMOFIX PLATE WAS THEN INSERTED INTO A SUBCUTANEOUS TUNNEL FORMED ON THE MEDIAL SIDE OF THE TIBIA AND FIXED IN PLACE WITH LOCKING SCREWS WITH MINIMAL INVASIVENESS. THE AUTHORS EVALUATED 14 KNEES IN 14 MEN AND 145 KNEES IN 145 WOMEN, COMPRISING 159 KNEES IN 159 PATIENTS. APPROXIMATELY 24.9 MONTHS AFTER SURGERY (RANGE, 22 TO 26 MONTHS), THE PATIENTS UNDERWENT SECOND-LOOK ARTHROSCOPIC EXAMINATIONS. THE MEAN AGE (STANDARD DEVIATION) OF THE PATIENTS AT THE TIME OF SECOND-LOOK ARTHROSCOPY WAS 60.2 +/-6.8 YEARS (RANGE, 41 TO 75 YEARS). CORRECTION FAILURE WAS FOUND IN 16 CASES WITH REVARIZATION AND 10 CASES WITH OVERCORRECTION. THERE WERE NO CASES OF NONUNION OR INFECTION IN THIS STUDY. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399892 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention