BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: TOMOFIX OSTEOTOMY

    MDR report key: 10513793 · Received September 10, 2020

    Report

    Report Number
    8030965-2020-06728
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    August 13, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. G5-510K: THIS REPORT IS FOR AN UNKNOWN TOMOFIX OSTEOTOMY PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN 2015 TO 2017. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: JI W, ET AL. (2019), A RESIDUAL INTRA-ARTICULAR VARUS AFTER MEDIAL OPENING WEDGE HIGH TIBIAL OSTEOTOMY (HTO) FOR VARUS OSTEOARTHRITIS OF THE KNEE, ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, VOLUME 139, PAGE 743-750, (CHINA). THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE WHETHER ANY RESIDUAL VARUS WAS LEFT INSIDE THE JOINT AFTER HIGH TIBIAL OSTEOTOMY IN PATIENTS WITH KNEE OSTEOARTHRITIS, AND A CORRELATION OF THE RESIDUAL VARUS COULD BE TRACED. FROM 2015 TO 2017, THE ENROLLED PATIENTS WITH MEDIAL KNEE OSTEOARTHRITIS UNDERWENT MEDIAL OPENING WEDGE. PATIENTS WERE EXCLUDED IF THEY EXPERIENCED COMPLICATIONS, SUCH AS BONE GRAFT COLLAPSE, BROKEN SCREWS, OR MALUNION OR NON-UNION AFTER SURGERY, AS SUCH CONDITIONS COULD ADVERSELY AFFECT LIMB ALIGNMENT. A TOTAL OF 66 PATIENTS (66 KNEES) WERE INCLUDED IN THE STUDY. THERE WERE 29 MALES AND 37 FEMALES WITH A MEAN AGE OF 63.2 YEARS (RANGE 51-82 YEARS), MEAN HEIGHT OF 167.1 CM (RANGE 152.3¿176.3), MEAN WEIGHT OF 61.1 KG (46.8¿83.1) AND MEAN BODY MASS INDEX OF 27.9 KG/SQUARE METER (RANGE 21.2¿43.4). ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES TOMOFIX PLATE AND UNKNOWN SYNTHES TOMOFIX PROXIMAL LOCKING SCREWS. FOR AN OSTEOTOMY GAP OF 13 MM OR MORE, THE GAP WAS FILLED WITH AUTOGENOUS CANCELLOUS BONE GRAFT. THE PERCENTAGE OF MECHANICAL AXIS, MECHANICAL FEMOROTIBIAL ANGLE, MECHANICAL LATERAL DISTAL FEMORAL ANGLE, MECHANICAL MEDIAL PROXIMAL TIBIAL ANGLE, AND JOINTLINE CONVERGENCE ANGLE (JLCA) WERE MEASURED ON RADIOGRAPHS OF THE FULL-LENGTH LEGS PREOPERATIVELY AND 6 MONTHS POSTOPERATIVELY. THE RELATIONSHIP BETWEEN CHANGES IN THE JLCA AND ALIGNMENT CORRECTION WAS ASSESSED. THE POSTOPERATIVE RESIDUAL JLCA WAS CATEGORIZED AS THE OPTIMAL (POSTOPERATIVE JLCA LESSER OR EQUAL TO 2 DEGREES), THE ACCEPTABLE (2 DEGREES LESSER POSTOPERATIVE JLCA LESSER OR EQUAL TO 5 DEGREES), AND THE UNACCEPTABLE (POSTOPERATIVE JLCA GREATER THAN) TO ANALYZE ITS CORRELATION WITH PRE- OR INTRA-OPERATIVE FACTORS. COMPLICATIONS WERE REPORTED AS FOLLOWS: UNKNOWN PATIENTS HAD BONE GRAFT COLLAPSE AFTER SURGERY AND WERE EXCLUDED FROM THE STUDY. UNKNOWN PATIENTS HAD BROKEN SCREWS AFTER SURGERY AND WERE EXCLUDED FROM THE STUDY. UNKNOWN PATIENTS HAD MALUNION AFTER SURGERY AND WERE EXCLUDED FROM THE STUDY. UNKNOWN PATIENTS HAD NON-UNION AFTER SURGERY AND WERE EXCLUDED FROM THE STUDY. 2 PATIENTS IN GROUP 3 HAD AN UNACCEPTABLE JOINT LINE CONVERGENCE ANGLE. 8 PATIENTS IN GROUP 4 HAD AN UNACCEPTABLE JOINT LINE CONVERGENCE ANGLE. THIS REPORT IS FOR THE UNKNOWN SYNTHES TOMOFIX PLATE AND UNKNOWN SYNTHES TOMOFIX PROXIMAL LOCKING SCREWS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR ONE (1) UNKNOWN TOMOFIX OSTEOTOMY PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982300 UNK - PLATES: TOMOFIX OSTEOTOMY PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention