BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 7597490 · Received June 13, 2018

    Report

    Report Number
    8030965-2018-54316
    Event Type
    Injury
    Date Received
    June 13, 2018
    Report Date
    May 24, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. THIS REPORT IS UNKNOWN QUANTITY OF UNKNOWN TOMOFIX PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER CONTACT NUMBER WAS NOT PROVIDED. THIS REPORT IS FOR UNKNOWN QUANTITY OF UNKNOWN TOMOFIX PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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: VAN DER WOUDE JAD, SPRUIJT S, VAN GINNEKEN BTJ, VAN HEERWAARDEN RJ (2016). DISTAL FEMORAL VALGUS OSTEOTOMY: BONE HEALING TIME IN SINGLE PLANE AND BIPLANAR TECHNIQUE. STRATEGIES IN TRAUMA AND LIMB RECONSTRUCTION. VOLUME 11. PAGES 177-186. ((B)(6)). THIS RETROSPECTIVE REVIEW PRESENTS THE TECHNIQUE AND RESULTS OF A CONSECUTIVE CASE SERIES OF LATERAL UNIPLANAR AND BIPLANAR CLOSED-WEDGE VALGUS OSTEOTOMY OF THE DISTAL FEMUR FOR THE TREATMENT OF VARUS DEFORMITY OF THE KNEE. A TOTAL OF 16 KNEES IN 15 PATIENTS (9 MALES AND 6 FEMALES WITH A MEAN MEDIAN AGE OF 45 ± 14 YEARS) WERE INCLUDED FOR THE TREATMENT. BETWEEN 2005 AND 2012, CLOSING-WEDGE OSTEOTOMY WAS PERFORMED USING EITHER AN UNKNOWN SYNTHES LATERAL DISTAL FEMUR TOMOFIX PLATE (LDF) OR WITH AN UNKNOWN SYNTHES MEDIAL DISTAL FEMORAL TOMOFIX PLATE (MDF). IN SIX KNEES, THE DFO WAS UNIPLANAR AND IN TEN BIPLANAR. AN ANGULAR STABLE LDF PLATE WAS USED IN TWELVE KNEES, AN ANGULAR STABLE MDF PLATE (CONTRALATERAL) IN THREE AND IN ONE KNEE, CLINICAL EVALUATION WAS DONE AT 6 WEEKS, 3 MONTHS, 6 MONTHS, 9 MONTHS AND 12 MONTHS POST-SURGERY. DURING THE FIRST 6 WEEKS PARTIAL (NO MORE THAN 15¿20 KG) WEIGHT-BEARING IS ALLOWED BETWEEN CRUTCHES. CLINICAL AND RADIOGRAPHIC PROOF OF BONE HEALING AT 6 WEEKS ENABLES PROGRESSIVE WEIGHT-TO-FULL-WEIGHT BEARING. THE CLINICAL RESULTS WERE ASSESSED AT A MEAN OF 40 MONTHS (±30) POST-OPERATIVELY. OSTEOARTHRITIS WAS CLASSIFIED ACCORDING TO K&L SCALE (KELLGREN AND LAWRENCE). GRADE 0 INDICATES NORMAL, GRADE 1 INDICATES MINIMUM OSTEOPHYTES, GRADE 2 INDICATES DEFINITE OSTEOPHYTE, GRADE 3 INDICATES MODERATE JOINT-SPACE REDUCTION AND GRADE 4 INDICATES SEVERE JOINT-SPACE NARROWING WITH SCLEROSIS AND OSTEOPHYTES. COMPLICATIONS WERE REPORTED AS FOLLOWS: THE 2 PATIENTS UNDERWENT AN ARTHROSCOPY, ONE OF THESE PATIENTS HAD TOTAL KNEE ARTHROPLASTY WITHIN 2 YEARS. THE 7 PATIENTS REQUIRED PLATE REMOVAL DUE TO TENDERNESS. THE 1 PATIENT HAD AN ACL-RECONSTRUCTION AS WELL AS AN OPEN-WEDGE VALGUS HIGH TIBIAL OSTEOTOMY WAS PERFORMED SEVERAL YEARS AFTER INDEX SURGERY FOR PROGRESSIVE SYMPTOMATIC MEDIAL OSTEOARTHRITIS CAUSING TIBIAL VARUS DEFORMITY AND INSTABILITY. AT FOLLOW-UP, THE MEAN VAS SCORE WAS 2.5 (±2.4). KELLGREN AND LAWRENCE SCALE: CASE 1 WITH A SCORE OF 4 POSTOPERATIVELY. CASE 2 WITH A SCORE OF 4 POSTOPERATIVELY. CASE 3 WITH A SCORE OF 3 POSTOPERATIVELY. . CASE 5 WITH A SCORE OF 2 POSTOPERATIVELY. CASE 6 WITH A SCORE OF 3 POSTOPERATIVELY. CASE 7 WITH A SCORE OF 2 POSTOPERATIVELY. CASE 8 WITH A SCORE OF 3 POSTOPERATIVELY. CASE 9 WITH A SCORE OF 3 POSTOPERATIVELY. CASE 10 WITH A SCORE OF 3 POSTOPERATIVELY. CASE 11 WITH A SCORE OF 2 POSTOPERATIVELY. CASE 12 WITH A SCORE OF 3 POSTOPERATIVELY. CASE 13 WITH A SCORE OF 3 POSTOPERATIVELY. CASE 14 WITH A SCORE OF 3 POSTOPERATIVELY. CASE 15 WITH A SCORE OF 3 POSTOPERATIVELY. THIS REPORT IS FOR AN UNKNOWN SYNTHES LATERAL DISTAL FEMUR TOMOFIX PLATE (LDF) OR WITH AN UNKNOWN SYNTHES MEDIAL DISTAL FEMORAL TOMOFIX PLATE (MDF). THIS REPORT IS 1 OF 1 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
    441177 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention