BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEVICE - TRANSFEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT

    MDR report key: 24872484 · Received April 14, 2026

    Report

    Report Number
    3029890418-2026-00004
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ALM ORTHO INC
    Product Code
    PJY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN EXPLANTED AS OF THIS DATE AND THEREFORE COULD NOT BE EVALUATED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY DESIGN OR MANUFACTURING DEFECTS. TREND ANALYSIS FOUND 6 CASES OF IMPLANT FRACTURE AND ALL EVENT OCCURRED WITHIN A PREVIOUSLY IDENTIFIED HIGHER RISK PATIENT SUBGROUP CHARACTERIZED BY SPECIFIC GEOMETRIC AND LOADING CONDITIONS. NO FRACTURES HAVE BEEN OBSERVED OUTSIDE OF THIS SUBGROUP.

    Description of Event or Problem · 0

    ON (B)(6) 2026 THE COMPANY RECEIVED NOTIFICATION FROM THE SURGEON THAT ONE OF HIS PATIENTS EXPERIENCED A DEVICE FAILURE. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT EXPERIENCED FAILURE WHILE PERFORMING A ROUTINE ACTIVITY, SPECIFICALLY WHILE WALKING THROUGH A MALL. THE REPORTED FAILURE MODE INDICATES THAT THE SHAFT OF THE TRANSFEMORAL BONE ANCHORED IMPLANT FRACTURED AT ITS BASE, RESULTING IN SEPARATION OF THE IMPLANT FROM THE DISTAL PORTION. WE ARE NOT AWARE OF ANY PATIENT INJURY OR PERMANENT FUNCTIONAL IMPAIRMENT AS A RESULT OF THIS EVENT. HOWEVER, THE PATIENT IS SCHEDULED FOR EXPLANTATION SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED CONCERNING THE EXPLANT SURGERY OR SUBSEQUENT CLINICAL MANAGEMENT OR PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90225 CUSTOM DEVICE - TRANSFEMORAL BONE ANCHORED OSSEOINTEGRATION IMPLANT OSSEOANCHORED PROSTHESIS FOR THE REHABILITATION OF TRANSFEMORAL AMPUTEES PJY ALM ORTHO INC 071725.08

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male