BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3749510 · Received April 14, 2014

    Report

    Report Number
    2520274-2014-10738
    Event Type
    Injury
    Date Received
    April 14, 2014
    Report Date
    March 21, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN TOMOFIX PLATE/UNKNOWN LOT. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. BODE, G., ET. AL. (19NOV2013) PROSPECTIVE 5-YEAR SURVIVAL RATE DATA FOLLOWING OPEN-WEDGE VALGUS HIGH TIBIAL OSTEOTOMY. KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY. FROM APRIL 2004 TO DECEMBER 2006, 62 PATIENTS SUFFERING FROM MEDIAL UNICOMPARTMENTAL OSTEOARTHRITIS OF THE KNEE WITH VARUS MALALIGNMENT (MINIMUM OF THREE DEGREES OF VARUS MALALIGNMENT) AND MEDIAL KNEE PAIN WERE TREATED WITH A MEDIAL OPEN-WEDGE OSTEOTOMY. IN ALL PATIENTS, A ROUTINE ARTHROSCOPY OF THE AFFECTED KNEE WAS PERFORMED PRIOR TO THE OSTEOTOMY TO EXCLUDE PATIENTS WITH FULL-THICKNESS CARTILAGE LESIONS OF THE LATERAL COMPARTMENT AND TO ASSESS THE ANTERIOR COMPARTMENT. OPEN-WEDGE HIGH TIBIAL OSTEOTOMY USING INTERNAL PLATE FIXATION IS A WELL-ESTABLISHED AND FREQUENTLY PERFORMED TREATMENT OPTION FOR THE MANAGEMENT OF MEDIAL COMPARTMENT OSTEOARTHRITIS IN THE YOUNG AND ACTIVE PATIENTS. THE PRESENT STUDY PROVIDES SURVIVAL RATE AND FUNCTIONAL OUTCOME PREOPERATIVELY AND AFTER 6, 12, 24, 36 AND 60 MONTHS FOLLOWING OPEN-WEDGE HIGH TIBIAL OSTEOTOMY. HYPOTHESIS OF THE AUTHORS WAS HIGH SURVIVAL RATES AFTER FIVE YEARS WITH STILL REMAINING SATISFYING FUNCTIONAL RESULTS. SIXTY-TWO PATIENTS SUFFERING FROM TIBIAL CONDITIONED KNEE JOINT VARUS DEFORMITY AND MEDIAL COMPARTMENT OSTEOARTHRITIS THAT UNDERWENT HIGH TIBIAL OSTEOTOMY USING AN INTERNAL PLATE FIXATOR (TOMOFIX, SYNTHES) WERE INCLUDED. AT THE TIME OF DATA COLLECTION, 51 OUT OF THE 62 PATIENTS WERE AVAILABLE FOR FOLLOW-UP EVALUATION. FUNCTIONAL OUTCOME WAS EVALUATED PRIOR TO SURGERY AND IN THE FURTHER CLINICAL COURSE USING STANDARD INSTRUMENTS (IKDC SCORE, LYSHOLM SCORE). TREATMENT FAILURE WAS DEFINED AS THE NEED FOR TOTAL KNEE ARTHROPLASTY. FIFTY-ONE PATIENTS WERE AVAILABLE AT A MEAN OF 60.5 MONTHS (FOLLOW-UP RATE 82.3 PERCENT) POSTOPERATIVELY. SIXTY-MONTH IKDC AND LYSHOLM (76.6 SD EQUAL TO OR GREATER THAN 20.5) IMPROVED SIGNIFICANTLY WHEN COMPARING WITH PREOPERATIVE VALUES (IKDC 44.6 SD EQUAL TO OR GREATER THAN 17.8; LYSHOLM 52.1 SD EQUAL TO OR GREATER THAN 20.8). TWO OF 51 SUBJECTS UNDERWENT TOTAL KNEE ARTHROPLASTY, RESULTING IN A SURVIVAL RATE OF 96 PERCENT AMONG THOSE PATIENTS FOLLOWED (51 OF 60; 85 PERCENT). OVERALL COMPLICATION RATE WAS 8.6 PERCENT. WITH A SURVIVAL RATE OF OVER 96 PERCENT AT 5 YEARS, HIGH TIBIAL OSTEOTOMY SEEMS TO BE A RELIABLE TREATMENT OPTION WITH SATISFYING CLINICAL OUTCOME. FUNCTIONAL OUTCOME WAS STABLE FOLLOWING 60 MONTHS. WHILE A DELAY OF THE NECESSITY FOR TOTAL KNEE ARTHROPLASTY SEEMS S LIKELY WITH REGARD TO THE SURVIVAL RATE DEMONSTRATED IN THIS ARTICLE, POSSIBLE AVOIDANCE NEEDS TO BE DEMONSTRATED BY LONGER FOLLOW-UP STUDIES. OTHER PATIENT OUTCOMES NOTED WERE ONE PATIENT WHO HAD AN INTRA-ARTICULAR FRACTURE OF THE LATERAL TIBIA PLATEAU-REQUIRED A REVISION WITH SCREW OSTEOSYNTHESIS. TWO PATIENTS WHO HAD DELAYED UNIONS. ANOTHER MENTION OF TWO PATIENTS WHO HAD DELAYED UNIONS WAS UNCLEAR IF IT WAS THE SAME TWO DELAYED UNIONS MENTIONED EARLIER. ONE PATIENT HAD A DISTURBED POST-OPERATIVE WOUND HEALING. THERE WERE 28 COMPLAINTS OF UNCOMFORTABLE IMPLANTS. THERE WERE THREE NOTED OVERCORRECTIONS DEFINED AS VALGIZATION OF MORE THAN 70 PERCENT OF THE TIBIAL PLATEAU WIDTH WAS PERFORMED. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226892 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention