BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24801838 · Received April 7, 2026

    Report

    Report Number
    1220246-2026-02005
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    July 1, 2019
    Report Date
    April 7, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 12-MAR-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2019 BY THE JOURNAL OF ARTHROSCOPIC & RELATED SURGERY, TITLED ¿RETURN TO SPORT AND WORK AFTER HIGH TIBIAL OSTEOTOMY WITH CONCOMITANT MEDIAL MENISCAL ALLOGRAFT TRANSPLANT". THE STUDY REVIEWED TWENTY-SIX (26) PATIENTS WHO UNDERWENT OPENING WEDGE HIGH TIBIA OSTEOTOMY, TO ADDRESS HIGH TIBIAL OSTEOTOMY, USING HTO WEDGE PLATES. DURING THE AVERAGE OF 9.3 ± 3.7 (RANGE, 3-13 YEARS) YEAR FOLLOW-UP PERIOD, FOUR (4) PATIENTS UNDERWENT HARDWARE REMOVAL FOR PAINFUL HARDWARE. SOURCE: LIU JN, AGARWALLA A, GARCIA GH, ET AL. RETURN TO SPORT AND WORK AFTER HIGH TIBIAL OSTEOTOMY WITH CONCOMITANT MEDIAL MENISCAL ALLOGRAFT TRANSPLANT. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC & RELATED SURGERY. 2019/11/01/ 2019;35(11):3090-3096. DOI:HTTPS://DOI.ORG/10.1016/J.ARTHRO.2019.05.053.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858867 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other