BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALM ORTHO - CUSTOM DEVICE - LEFT FEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT

    MDR report key: 24351350 · Received February 16, 2026

    Report

    Report Number
    3029890418-2026-00002
    Event Type
    Injury
    Date Received
    February 16, 2026
    Report Date
    February 16, 2026
    Manufacturer
    ALM ORTHO, INC
    Product Code
    PJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FRACTURE OCCURRED AFTER THE SLIPPED AND FELL DUE TO ICY CONDITIONS. THE DEVICE WAS NOT RETURNED. IT IS NOT KNOWN IF THE CAUSE OF THE FRACTURE WAS DUE TO THE FALL OR ANOTHER CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND AY DESIGN OR MANUFACTURING DEFECTS.

    Description of Event or Problem · 0

    ON JANUARY 21, 2026, THE COMPANY RECEIVED NOTIFICATION FROM THE PATIENT THAT HE EXPERIENCED A DEVICE FAILURE AFTER SLIPPING AND FALLING DUE TO ICY CONDITIONS. ACCORDING TO THE INFORMATION PROVIDED BY THE PATIENT THE SHAFT OF THE TRANSFEMORAL BONE-ANCHORED IMPLANT, FRACTURED AT ITS BASE, RESULTING IN SEPARATION OF THE IMPLANT FROM THE DISTAL PORTION. THE PATIENT UNDERWENT EXPLANTATION SURGERY ON (B)(6) 2026. THE COMPANY IS UNAWARE OF ANY SIGNIFICANT STATUS CHANGE WITH THE PATIENT CONDITION BEYOND STATUS POST-OP OF IMPLANT REMOVAL. NO ADDITIONAL INFORMATION REGARDING SUBSEQUENT CLINICAL MANAGEMENT OR PATIENT OUTCOME HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409242 ALM ORTHO - CUSTOM DEVICE - LEFT FEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT OSSEOANCHORED PROSTHESES FOR THE REHABILITATION OF TRANSFEMORAL AMPUTEES PJY ALM ORTHO, INC 021025.03A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention