BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP

    MDR report key: 25135953 · Received May 11, 2026

    Report

    Report Number
    8030965-2026-04448
    Event Type
    Injury
    Date Received
    May 11, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (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: CHEN P, YU J, GUO H, YUWEN P, ZHU Y, ZHANG Y. CLINICAL OUTCOME AFTER OPEN-WEDGE HIGH TIBIAL OSTEOTOMY: COMPARISON OF DOUBLE-TRIANGLE LOCKING COMPRESSION PLATE (DT-LCP) AND T-SHAPED LOCKING COMPRESSION PLATE (T-LCP). BMC MUSCULOSKELET DISORD. 2024 AUG 1;25(1):609. DOI: 10.1186/S12891-024-07658-W. PMID: 39085837; PMCID: PMC11292875. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS SINGLE CENTER RETROSPECTIVE COHORT STUDY WAS TO INVESTIGATE THE EFFICACY AND COMPLICATION RATE OF DOUBLE-TRIANGLE LOCKING COMPRESSION PLATE (DT-LCP) WITH T-SHAPED LOCKING COMPRESSION PLATE (T-LCP) AS THE CONTROL GROUP. BETWEEN JANUARY 2018 AND DECEMBER 2021, A TOTAL OF 202 PATIENTS WITH KNEE OSTEOARTHRITIS (KOA) WERE INCLUDED IN THE ANALYSIS, 143 FEMALES AND 59 MALES, AGED FROM 39 TO 81 YEARS (64 ± 7). THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON INTERNAL FIXATION METHODS (GROUP 1, 98 PATIENTS OBTAINED DT-LCP FIXATION; GROUP 2, 104 PATIENTS OBTAINED T-LCP FIXATION). THE AVERAGE FOLLOW-UP TIME WAS 21 ± 8 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DOUBLE-TRIANGLE LOCKING COMPRESSION PLATE (DT-LCP) AND T-SHAPED LOCKING COMPRESSION PLATE (T-LCP) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP (QTY 19): QTY 2: 2 CASES OF IMPLANT IRRITATION REQUIRING PLATE REMOVAL. QTY 10: 10 CASES OF DEEP VEIN THROMBOSIS. INTERVENTION WAS NOT DISCUSSED. QTY 3: 3 CASES OF LEG WEAKNESS. INTERVENTION WAS NOT DISCUSSED. QTY 3: 3 CASES OF INFECTIONS. INTERVENTION WAS NOT DISCUSSED. QTY 1: 1 CASES OF LATERAL HINGE FRACTURE. INTERVENTION WAS NOT DISCUSSED ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: 3.5 MM LCP T-PLATE (QTY 35): QTY 15: 15 CASES OF IMPLANT IRRITATION REQUIRING PLATE REMOVAL. QTY 11: 11 CASES OF DEEP VEIN THROMBOSIS. INTERVENTION WAS NOT DISCUSSED. INTERVENTION WAS NOT DISCUSSED. QTY 3: 3 CASES OF LEG WEAKNESS. INTERVENTION WAS NOT DISCUSSED. QTY 4: 4 CASES OF INFECTIONS. INTERVENTION WAS NOT DISCUSSED. QTY 2: 2 CASES OF LATERAL HINGE FRACTURES. INTERVENTION WAS NOT DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510660 UNK - CONSTRUCTS: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1