BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL DISTAL FEMUR

    MDR report key: 22095297 · Received May 28, 2025

    Report

    Report Number
    8030965-2025-05289
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    August 11, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL MANUFACTURER NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (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. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MAIONE A, RICCI M, CALANNA F, PARMIGIANI MD, MENON A, USELLINI E, RANDELLI PS, BERRUTO M. OUTCOMES OF MEDIAL CLOSING-WEDGE DISTAL FEMORAL OSTEOTOMY FOR FEMORAL- AND TIBIAL-BASED VALGUS DEFORMITY. AM J SPORTS MED. 2024 AUG;52(10):2524-2531. DOI: 10.1177/03635465241262437. EPUB 2024 AUG 11. PMID: 39129248. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ASSESS THE CLINICAL AND RADIOLOGICAL OUTCOMES OF MEDIAL CLOSING-WEDGE DFO (MCW-DFO) FOR THE TREATMENT OF VALGUS KNEES, CONSIDERING BOTH TIBIAL- AND FEMORAL-BASED DEFORMITIES, AS WELL AS TO VERIFY THE EFFICACY AND SAFETY OF MCW-DFO ACCORDING TO JLO BOUNDARIES (=4°). BETWEEN 2001 AND 2020, A TOTAL OF 30 PATIENTS (22 MALE AND 8 FEMALE; 34 KNEES) WITH A MEAN AGE OF 49.3 ± 9.1 YEARS, UNDERWENT MCW-DFO USING A PLATE AND SCREWS (TOMOFIX MDF; DEPUY SYNTHES). PATIENTS WERE THEN DIVIDED INTO 2 GROUPS, FB-V AND TB-V, DEPENDING ON THE LOCATION OF THE DEFORMITY, MEASURED AS A LATERAL DISTAL FEMORAL ANGLE (LDFA) <85° OR MEDIAL PROXIMAL TIBIAL ANGLE (MPTA) >90° BEFORE THE OPERATION. THE OVERALL MEAN FOLLOW-UP WAS 9.48 ± 5.93 YEARS (MEAN FOLLOW-UP IN TB-V GROUP, 8.02 ± 4.94 VS FB-V GROUP, 10.93 ± 6.61 YEARS). 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 DISTAL FEMUR (QTY 7): 1 PATIENT HAD HINGE FRACTURE OCCURRED INTRAOPERATIVELY IN THE TB-V GROUP, WHO THEN EXPERIENCED HYPERTROPHIC NONUNION AND UNDERWENT A REVISION 3 YEARS AFTER THE OSTEOTOMY (DEVICE REMOVAL, GAP FILLING WITH SYNTHETIC BONE GRAFT, AND NEW FIXATION WITH DOUBLE PLATING AND SCREWS). 1 PATIENT IN THE TB-V GROUP, WAS DIAGNOSED WITH PSORIATIC ARTHRITIS AFTER SURGERY WITH NO INFLUENCE ON THE CLINICAL RESULTS. 1 PATIENT IN THE FB-V GROUP, DEVELOPED ANEMIA AND THROMBOCYTOPENIA AFTER THE OPERATION, RESULTING IN A LONGER HOSPITAL STAY; INTERVENTION NOT REPORTED. 1 PATIENT IN THE FB-V GROUP, HAD A TRANSIENT NEUROLOGIC PALSY OF THE SAPHENOUS NERVE WAS REPORTED WITH A COMPLETE RECOVERY WITHIN 6 MONTHS WITH A SUPPLY OF NEUROTROPHIC DRUGS. DURING THE WHOLE FOLLOW-UP PERIOD, ONLY 1 CONVERSION TO TOTAL KNEE ARTHROPLASTY (TKA; 2.9%) WAS RECORDED IN THE TB-V GROUP, 14 YEARS AFTER THE OSTEOTOMY, WHILE 2 PATIENTS IN THE FB-V GROUP UNDERWENT AN ARTHROSCOPIC DEBRIDEMENT 1 AND 9 YEARS AFTER THE PROCEDURE BECAUSE OF PAIN AND JOINT STIFFNESS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715241 UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS: MEDIAL DISTAL FEMUR PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention