BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: DHS/DCS

    MDR report key: 23961856 · Received January 5, 2026

    Report

    Report Number
    8030965-2026-00099
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 11, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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: 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: GRÉGOIRE CHÂTELIER, ROMAIN HUGUET, IGOR BENEZIS, JOHAN LEBECQUE. FEMORAL NECK SYSTEM VS CONVENTIONAL FIXATION: LONG-TERM OUTCOMES FROM A SINGLE-CENTER STUDY. JOURNAL OF ORTHOPAEDICS, VOLUME 73,2026, PAGES 95-100, ISSN 0972-978X, HTTPS://DOI.ORG/10.1016/J.JOR.2025.12.021. (CITATION ON PUBMED: NOT FOUND). OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS RETROSPECTIVE STUDY COMPARES OUTCOMES OF FNS VERSUS DYNAMIC HIP SCREW (DHS) AND TRIPLE SCREWS (TS) IN ALL PATIENTS HOSPITALIZED FOR FEMORAL NECK FRACTURES AND TREATED SURGICALLY WITHIN THE PAST TWO YEARS AND IN CORPORATES RECENT LITERATURE TO EVALUATE ITS EFFECTIVENESS AND SAFETY. BETWEEN JANUARY 2020 AND OCTOBER 2022, A TOTAL OF 143 PATIENTS WERE INCLUDED IN THE STUDY (MEAN AGE 78.7 ± 13.8 YEARS; 84 WOMEN) OF WHICH 31 (MEAN AGE 77.3 ±13.6 YEARS; 19 WOMEN) WERE TREATED WITH FNS, 62 (MEAN AGE 82.2 ±10.5 YEARS; 40 WOMEN) UNDERWENT PERCUTANEOUS TRIPLE CANNULATED SCREW FIXATION (TS), AND 50 (MEAN AGE 75.3 ±16.5 YEARS; 25 WOMEN) RECEIVED DYNAMIC HIP SCREW PLATING (DHS). MEAN FOLLOW-UP WAS APPROXIMATELY TWO YEARS ENABLING DETECTION OF LATER COMPLICATIONS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: FEMORAL NECK SYSTEM (FNS) AND DYNAMIC HIP SCREW (DHS). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: FNS (QTY 18): (N=9) REOPERATIONS, (N=2) FAILURE FIXATION, (N=6) NECROSIS, (N=1) INFECTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: DHS/DCS (QTY 28): (N=13) REOPERATIONS, (N=9) FAILURE FIXATION, (N=6) NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618843 UNK - CONSTRUCTS: DHS/DCS APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention