BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7617056 · Received June 19, 2018

    Report

    Report Number
    2939274-2018-52551
    Event Type
    Injury
    Date Received
    June 19, 2018
    Report Date
    May 24, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX PLATES/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (510K): UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR TOMOFIX PLATE IS NOT PROVIDED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SWARUP I, ELATTAR O, ROZBRUCH SR (2017). PATELLAR INSTABILITY TREATED WITH DISTAL FEMORAL OSTEOTOMY. THE KNEE. VOLUME 24. PAGES 608-614. (USA) THIS RETROSPECTIVE STUDY PRESENTS AN EXPERIENCE WITH DISTAL FEMORAL OSTEOTOMY (DFO) FOR GENU VALGUM WITH ASSOCIATED PATELLAR INSTABILITY. THE GOAL OF THE STUDY IS TO INCREASE THE AWARENESS OF THE RELATIONSHIP BETWEEN GENU VALGUM AND PATELLAR INSTABILITY, AS WELL AS DESCRIBE A SUCCESSFUL AND RELIABLE TREATMENT OPTION FOR THIS COMPLEX PROBLEM. EIGHT PATIENTS UNDERWENT A LATERAL OPENING WEDGE DFO BETWEEN JUNE 2010 AND OCTOBER 2014. A TOTAL OF 10 KNEES WERE INCLUDED IN THE ANALYSIS (SIX UNILATERAL AND TWO BILATERAL DFO WITH LATERAL RETINACULAR RELEASE). THE GOAL WAS TO CORRECT THE VALGUS DEFORMITY. ALL OSTEOTOMIES WERE FIXED USING AN UNKNOWN SYNTHES TOMOFIX LOCKING PLATE. ALL PATIENTS WERE FEMALE. THE MEAN AGE AT THE TIME OF SURGERY WAS 50 (RANGE 23-68) YEARS. MEAN FOLLOW-UP DURATION WAS 27 MONTHS (RANGE: FIVE MONTHS TO 52 MONTHS). THE PRIMARY OUTCOME OF INTEREST IS TO EVALUATE THE CHANGE OR IMPROVEMENT IN PATELLA CONGRUENCY ANGLE (PCA) WITH SURGERY. KOOS-PS SCORES RANGE FROM 0 TO 100 WITH LOWER SCORES REPRESENTING NO DIFFICULTY. VAS PAIN SCORES RANGED FROM 0 TO 10 WITH LOWER VALUES REPRESENTING LESS PAIN. THE KUJALA QUESTIONNAIRE IS A VALIDATED OUTCOME MEASURE FOR PATELLOFEMORAL DISORDERS, INCLUDING PATELLAR SUBLUXATION AND DISLOCATION. HIGHER KUJALA SCORES REPRESENT LESS SYMPTOMS AND FUNCTIONAL LIMITATION COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD DELAYED UNION AND WAS TREATED WITH ILIAC CREST BONE GRAFTING, AND SUBSEQUENTLY PROGRESSED TO UNION. A (B)(6) FEMALE WHO HAD A LEFT PATELLAR SUBLUXATION HAS A POST-OP VAS PAIN SCORE OF 2. A (B)(6) FEMALE WHO HAD A RIGHT PATELLAR SUBLUXATION HAS A POST-OP VAS PAIN SCORE OF 4. HER KUJALA SCORE DECREASED FROM 73 POST-OP TO 71 PRE-OP. HER KOOS-PS SCORE INCREASED FROM 22 PRE-OP TO 24.9 POST-OP. A (B)(6) FEMALE WHO HAD A RIGHT PATELLAR DISLOCATION HAD AN INCREASE OF KOOS-PS SCORE FROM 10.5 PRE-OP TO 14.8 POST-OP. A (B)(6) FEMALE WHO HAD BILATERAL SUBLUXATION HAS A POST-OP VAS PAIN SCORE OF 1 ON HER LEFT KNEE AND 2.5 ON HER RIGHT KNEE. A (B)(6) FEMALE WHO HAD BILATERAL SUBLUXATION HAS A POST-OP VAS PAIN SCORE OF 2 BOTH KNEES. THIS REPORT IS FOR A PATIENT WHO HAD DELAYED UNION AND WAS TREATED WITH ILIAC CREST BONE GRAFTING, AND SUBSEQUENTLY PROGRESSED TO UNION. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX PLATES. THIS IS REPORT 1 OF 6 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456712 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention