BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP

    MDR report key: 25135857 · Received May 11, 2026

    Report

    Report Number
    8030965-2026-04447
    Event Type
    Injury
    Date Received
    May 11, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. 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: CHAVAN ET AL. INCIDENCE OF COMPLICATIONS FOLLOWING MANAGEMENT OF DISTAL FEMUR FRACTURE USING LOCKING COMPRESSION PLATE: A LONGITUDINAL STUDY; INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CLINICAL RESEARCH 2023; 15 (12); 1326-1330; E-ISSN: 0975-1556, P-ISSN: 2820-2643. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS PROSPECTIVE STUDY IS TO STUDY THE INCIDENCE OF COMPLICATIONS FOLLOWING MANAGEMENT OF DISTAL FEMUR FRACTURE USING LOCKING COMPRESSION PLATE. DURING THE STUDY PERIOD OF JANUARY 2018 TO JUNE 2019, A TOTAL OF 42 CASES OF DISTAL FEMUR FRACTURES TREATED WITH LCP DURING 18- MONTH PERIOD IN OUR HOSPITAL. PATIENTS WITH DISTAL FEMUR FRACTURE ARE ADMITTED AND EXAMINED ACCORDING TO PROTOCOL BOTH CLINICALLY AND RADIOLOGICALLY. ALL PATIENTS AGE >18YEARS, THERE WERE 32 MALES (76.2%) AND 10 (23.8%) FEMALES. MALE PREPONDERANCE WAS SEEN WITH MALE TO FEMALE RATIO AS 3.2:1. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES LCP ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: LCP (QTY 49): -2 PATIENTS HAD SHORTENING OF LEG; NO INTERVENTION WAS MENTIONED. -2 CASES OF VARUS; NO INTERVENTION WAS MENTIONED. -3 PATIENTS HAD PREVALENCE OF INFECTION; NO INTERVENTION WAS MENTIONED. -2 PATIENTS HAD INFECTION WITH COMPOUND FRACTURES; NO INTERVENTION WAS MENTIONED. -1 PATIENT HAD INFECTION WITH CLOSED FRACTURE; NO INTERVENTION WAS MENTIONED. -17 PATIENTS HAD MOVEMENT RESTRICTION POST OPERATIVELY; NO INTERVENTION WAS MENTIONED. -14 PATIENTS HAD MOVEMENT RESTRICTION IN FLEXION; NO INTERVENTION WAS MENTIONED. -3 PATIENTS HAD MOVEMENT RESTRICTION IN EXTENSION LAG; NO INTERVENTION WAS MENTIONED. -3 PATIENTS HAD EXTENSOR LAG WAS BETWEEN 6-10 DEGREES; NO INTERVENTION WAS MENTIONED. -2 PATIENTS HAD EXTENSOR LAG IN MORE THAN 10 DEGREES; NO INTERVENTION WAS MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452374 UNK - CONSTRUCTS: LCP PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1