BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA

    MDR report key: 22175548 · Received June 10, 2025

    Report

    Report Number
    8030965-2025-05790
    Event Type
    Injury
    Date Received
    June 10, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01) GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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 · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PARK JY, KIM JH, CHO JW, KIM MS, CHOI W. CLINICAL AND RADIOLOGICAL RESULTS OF HIGH TIBIAL OF OSTEOTOMY OVER THE AGE OF 65 ARE COMPARABLE TO THAT OF UNDER 55 AT MINIMUM 2-YEAR FOLLOW-UP: A PROPENSITY SCORE MATCHED ANALYSIS. KNEE SURG RELAT RES. 2024 FEB 28;36(1):10. DOI: 10.1186/S43019-024-00214-9. PMID: 38419060; PMCID: PMC10900727. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE CLINICAL AND RADIOLOGICAL OUTCOMES AFTER MEDIAL OPEN WEDGE HIGH TIBIAL OSTEOTOMY (MOWHTO) IN DIFFERENT AGE GROUPS. A TOTAL OF 205 PATIENT WHO UNDERWENT MOWHTO FROM JULY 2009 TO AUGUST 2020 WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE AGES. PROPENSITY SCORE MATCHING (PSM) WAS PERFORMED TO MINIMIZE SELECTION BIAS FOR MOWHTO BETWEEN TWO GROUPS. THE STUDY POPULATION CONSISTED OF 62 PARTICIPANTS IN EACH OF TWO AGE GROUPS: AN OLDER GROUP (>65 YEARS: 16 MALE AND 46 FEMALE) AND A YOUNGER GROUP (<55 YEARS: 16 MALE AND 46 FEMALE). THE MEAN AGE OF THE OLDER GROUP WAS 68.9±3.3 YEARS, WHICH WAS SIGNIFICANTLY HIGHER THAN THAT OF THE YOUNGER GROUP (51.7±2.9 YEARS). SURGERY WAS PERFORMED USING TOMOFIX DEVICE (DEPUY SYNTHES). THE FOLLOW-UP PERIOD WAS 50.4 MONTHS IN THE OLDER GROUP AND 55.3 MONTHS IN THE YOUNGER GROUP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES TOMOFIX ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA (QTY 41): - 7 CASES OF TKA CONVERSION IN THE OLDER GROUP. THE AVERAGE TIME TO TKA CONVERSION WAS 67 MONTHS. (42 MONTHS TO 90 MONTHS). - 18 PATIENTS IN OLDER GROUP HAD LATERAL HINGE FRACTURES; NO INTERVENTION NOTED. - 15 PATIENTS IN YOUNGER GROUP HAD LATERAL HINGE FRACTURES; NO INTERVENTION NOTED. - 1 CASE OF WOUND PROBLEM IN OLDER GROUP; NO INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355523 UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL HIGH TIBIA PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention