BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - PLATES: LCP

    MDR report key: 25182405 · Received May 15, 2026

    Report

    Report Number
    8030965-2026-04609
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 25, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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: CHANDAN KUMAR JHA, CLINICAL OUTCOME ASSESSMENT OF THE MANAGEMENT OF DISTAL FEMUR FRACTURES USING LOCKING COMPRESSION PLATES,INTERNATIONAL JOURNAL OF CURRENT PHARMACEUTICAL REVIEW AND RESEARCH 2024; 16(4); 474-478 (PUBMED CITATION NOT AVAILABLE). OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THE PRESENT STUDY WAS TO ASSESS THE CLINICAL OUTCOME OF TREATMENT OF DISTAL FEMUR FRACTURES USING LOCKING COMPRESSION PLATES. A TOTAL OF N=30 CASES ( 18 (60%) WERE MALES, 12 (40%) WERE FEMALES.) WERE INCLUDED FOR THE STUDY WITH FRACTURE LOWER END OF FEMUR FIXED WITH LCP. FOLLOW-UP IS UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES, LOCKING COMPRESSION PLATES . ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP (QTY 6). (N=1) PATIENT DEVELOPED SUPERFICIAL WOUND INFECTION IN 1ST WEEK AND WAS PROMPTLY TREATED WITH APPROPRIATE ANTIBIOTICS, WOUND CARE AND SECONDARY SUTURING. (N=1) PATIENT HAD DELAYED WOUND HEALING BUT WAS OTHERWISE UNEVENTFUL, NO INTERVENTION PROVIDE. (N=1) PATIENT DEVELOPED A TIBIAL PIN TRACT INFECTION, NO INTERVENTION PROVIDE. (N=1) PATIENT HAD KNEE STIFFNESS, NO INTERVENTION PROVIDED. (N=2) PATIENT HAD MALUNION WITH VARUS, NO INTERVENTION PROVIDED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: LCP (QTY 1) (N=1) PATIENT HAD PLATE BREAKAGE, NO INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110173 UNK - PLATES: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1