BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24801998 · Received April 7, 2026

    Report

    Report Number
    1220246-2026-02009
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    July 1, 2021
    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 2021 BY THE JOURNAL OF CARTILAGE & JOINT PRESERVATION, TITLED ¿PATIENT FACTORS PREDICTIVE OF FAILURE FOLLOWING HIGH TIBIAL OSTEOTOMY". THE STUDY REVIEWED SEVENTY-FIVE (75) PATIENTS WHO UNDERWENT OPENING WEDGE HIGH TIBIA OSTEOTOMY, TO ADDRESS HIGH TIBIAL OSTEOTOMY (HTO) FOR UNICOMPARTMENTAL KNEE PAIN WITH VARUS DEFORMITY, USING HTO WEDGE PLATES. DURING THE MEAN: 5.5 ± 3.8 YEAR FOLLOW-UP PERIOD, TWO (2) PATIENTS EXPERIENCED NONUNION. SOURCE: GILAT R, PATEL S, KNAPIK DM, ET AL. PATIENT FACTORS PREDICTIVE OF FAILURE FOLLOWING HIGH TIBIAL OSTEOTOMY. JOURNAL OF CARTILAGE & JOINT PRESERVATION. 2021/06/01/ 2021;1(2):100012. DOI:HTTPS://DOI.ORG/10.1016/J.JCJP.2021.100012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857398 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other