BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24806940 · Received April 7, 2026

    Report

    Report Number
    1220246-2026-02027
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    July 1, 2022
    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 2022 BY THE ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, TITLED ¿LONG-TERM FOLLOW-UP RESULTS OF MEDIAL OPENING WEDGE HIGH TIBIA OSTEOTOMY WITH A PRE-COUNTERED NON-LOCKING STEEL PLATE". THE STUDY REVIEWED SEVENTY (70) PATIENTS WHO UNDERWENT OPENING WEDGE HIGH TIBIA OSTEOTOMY, TO ADDRESS MEDIAL KNEE OSTEOARTHROSIS (OA)/MEDIAL OPENING WEDGE HIGH TIBIAL OSTEOTOMY (MOWHTO) WITH A PRE-COUNTERED NON-LOCKING STEEL PLATE IMPLANT (PUDDU PLATE = PP). DURING THE MEAN: 11.4 (SD 4.5; RANGE 1.2¿16.1) YEAR FOLLOW-UP PERIOD, NINETEEN (19) PATIENTS EXPERIENCED MODERATE/HARD PERSISTENT PAIN OR IMPLANT IRRITATION RESULTING IN REVISION. SOURCE: MIETTINEN SSA, MIETTINEN HJA, JALKANEN J, JOUKAINEN A, KRÖGER H. LONG-TERM FOLLOW-UP RESULTS OF MEDIAL OPENING WEDGE HIGH TIBIA OSTEOTOMY WITH A PRE-COUNTERED NON-LOCKING STEEL PLATE. ARCH ORTHOP TRAUMA SURG. NOV 2022;142(11):3111-3121. DOI:10.1007/S00402-021-03927-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863258 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other