BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24800147 · Received April 7, 2026

    Report

    Report Number
    1220246-2026-01988
    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 KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY, TITLED ¿A HINGE POSITION DISTAL TO THE ADDUCTOR TUBERCLE MINIMIZES THE RISK OF HINGE FRACTURES IN LATERAL OPEN WEDGE DISTAL FEMORAL OSTEOTOMY". THE STUDY REVIEWED TWENTY-ONE (21) PATIENTS WHO UNDERWENT OPENING WEDGE LDFO (LATERAL DISTAL FEMORAL OSTEOTOMY) USING ARTHREX PEEKPOWER LDFO PLATE TO ADDRESS OPENING WEDGE LATERAL DISTAL FEMORAL OSTEOTOMY FOR SYMPTOMATIC VALGUS MALALIGNMENT. IT WAS REPORTED THAT SEVEN (7) PATIENTS EXPERIENCED HINGE FRACTURES. SOURCE WINKLER, P. W., RUPP, M. C., LUTZ, P. M., GEYER, S., FORKEL, P., IMHOFF, A. B., & FEUCHT, M. J. (2021). A HINGE POSITION DISTAL TO THE ADDUCTOR TUBERCLE MINIMIZES THE RISK OF HINGE FRACTURES IN LATERAL OPEN WEDGE DISTAL FEMORAL OSTEOTOMY. KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY: OFFICIAL JOURNAL OF THE ESSKA, 29(10), 3382¿3391. HTTPS://DOI.ORG/10.1007/S00167-020-06244-6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860324 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other