BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: DHS/DCS

    MDR report key: 24924337 · Received April 20, 2026

    Report

    Report Number
    8030965-2026-03587
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    January 19, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ALM CE, KARLSTEN A, MADSEN JE, NORDSLETTEN L, BRATTGJERD JE, PRIPP AH, FRIHAGEN F, RÖHRL SM. NO BENEFIT OF THE TROCHANTERIC STABILIZING PLATE ON LOSS OF FRACTURE REDUCTION IN AO/OTA 31-A2 TROCHANTERIC FRACTURES. BONE JT OPEN. 2024 JAN 19;5(1):37-45. DOI: 10.1302/2633-1462.51.BJO-2023-0082.R1. PMID: 38240179; PMCID: PMC10797560. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF THE TSP IN A RCT COMPARING SECONDARY FRACTURE DISPLACEMENT, MEASURED BY RSA, IN UNSTABLE TROCHANTERIC FRACTURES (AO/OTA 31-A2) OPERATED WITH SHS WITH OR WITHOUT AN ADDITIONAL TROCHANTERIC STABILIZING PLATE. BETWEEN NOVEMBER 2014 AND DECEMBER 2016, 31 PATIENTS WITH AO/OTA 31-A2 TROCHANTERIC FRACTURES WERE ENROLLED IN THE STUDY AFTER PROVIDING WRITTEN INFORMED CONSENT. THE INCLUSION CRITERIA WERE AO/OTA TYPE 31-A2 TROCHANTERIC FRACTURE, AGED OVER 50 YEARS, ABLE TO WALK INDEPENDENTLY WITH OR WITHOUT AIDS, ABLE TO CONSENT, AND FIT FOR SURGERY. AFTER CONFIRMATION OF WIRE PLACEMENT AND SCREW LENGTH MEASUREMENT, PREPARATION FOR THE BARREL AND LAG SCREW WERE PERFORMED WITH THE DHS TRIPLE REAMER. THE FRACTURES WERE FIXED USING THE LCP DHS (DEPUY SYNTHES, USA) WITH OR WITHOUT A TSP (DEPUY SYNTHES) DEPENDING ON THE RANDOMIZATION. UNDER SHS, A TOTAL NUMBER OF PATIENTS WAS 14 (9 WERE FEMALE), WITH A MEDIAN AGE OF 79 (67 TO 87). WHILE IN SHS WITH TSP, 17 PATIENTS WERE INCLUDED. 17 WERE FEMALE WITH A MEDIAN AGE OF 88 (62 TO 94). THE PRIMARY OUTCOME MEASURE IN THE STUDY WAS MIGRATION OF THE FEMORAL HEAD/NECK FRAGMENT RELATIVE TO THE SHAFT, MEASURED BY RSA, EXPRESSED AS TOTAL TRANSLATION (T3D) AT ONE YEAR. SECONDARY OUTCOMES WERE TRANSLATION AND ROTATION AROUND THE X-, Y, AND Z-AXIS AT ALL TIME POINTS. INITIALLY, THERE WERE 32 PARTICIPANTS, ONE WAS EXCLUDED DUE TO WITHDRAWAL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES LCP DHS AND TROCHANTERIC STABILIZING PLATE (TSP). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: DHS/DCS (QTY 3): FIXATION FAILURE (N=3) TREATMENT: TOTAL HIP ARTHROPLASTY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: TSP (QTY 2): FIXATION FAILURE (N=2) TREATMENT: TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7627 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