BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24802030 · Received April 7, 2026

    Report

    Report Number
    1220246-2026-02010
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    July 1, 2018
    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 2018 BY THE INJURY., TITLED ¿TREATING PATELLA FRACTURES WITH A LOCKING PATELLA PLATE - FIRST CLINICAL RESULTS". THE STUDY REVIEWED THIRTY-FIVE (35) PATIENTS WHO UNDERWENT FRACTURE FIXATION USING PATELLA SUTUREPLATE (ARTHREX) TO ADDRESS DISLOCATED FRACTURES OF THE PATELLA. DURING THE SEVENTY-FIVE (75) MONTH FOLLOW-UP PERIOD, ONE (1) PATIENT EXPERIENCED IMPLANT FAILURE WITH SECONDARY FRACTURE DISLOCATION. SOURCE: WURM S, BÜHREN V, AUGAT P. TREATING PATELLA FRACTURES WITH A LOCKING PATELLA PLATE - FIRST CLINICAL RESULTS. INJURY. JUN 2018;49 SUPPL 1:S51-S55. DOI:10.1016/S0020-1383(18)30304-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858364 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other