BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: LCP DISTAL HUMERUS

    MDR report key: 25185584 · Received May 15, 2026

    Report

    Report Number
    8030965-2026-04620
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 26, 2025
    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). 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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: KURPAD SR. SURGICAL MANAGEMENT OF OSTEOPOROTIC FRACTURES: HUMERUS SHAFT FRACTURES. INDIAN J ORTHOP. 2025 APR 26;59(8):1053-1077. DOI: 10.1007/S43465-025-01379-5. PMID: 40852542; PMCID: PMC12367638. OBJECTIVE/METHODS/STUDY DATA: THE STUDY PRESENT THE SURGICAL OPTIONS FOR REDUCTION AND STABILIZATION, CHOICE OF IMPLANTS AND SURGICAL APPROACHES (INTERLOCKED NAILING¿ANTEGRADE OR RETROGRADE, AND PLATING¿DCP OR LOCKING PLATES) WITH INTER-SE MERITS AND DEMERITS IS DISCUSSED AS THERE IS NO CLEAR SUPERIORITY OF ONE METHOD OVER THE OTHER, ALONG WITH MEASURES TO MINIMIZE RISK OF ADVERSE EVENTS. THE MANAGEMENT OF SIGNIFICANT CHALLENGES WITH NON-UNIONS AND PERI-IMPLANT HUMERUS SHAFT FRACTURES IN OSTEOPOROTIC BONE ARE OUTLINED. 2 YEARS EARLIER A PATIENT HAD HUMERUS SHAFT FRACTURE AFTER A TRIVIAL FALL, WENT ON TO UNITE AFTER OPEN REDUCTION AND DORSAL PLATING USING LCP PLATE. 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 DISTAL HUMERUS PLATE/SCREWS (QTY 1): -1 PATIENT HAD DISTAL HUMERUS FRACTURE AT TIP OF EXISTING LCP, SUSTAINED WHEN THE ARM TWISTED WHILE LIFTING GRANDCHILD (TODDLER); OLD IMPLANTS (STAINLESS STEEL LCP) AND SCAR TISSUE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27666 UNK - CONSTRUCTS: LCP DISTAL HUMERUS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1