BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCANDINAVIAN TOTAL ANKLE REPLACEMENT

    MDR report key: 11692984 · Received April 19, 2021

    Report

    Report Number
    MW5100847
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 15, 2021
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HISTORY: I RECEIVED A STAR TOTAL ANKLE REPLACEMENT (STRYKER) BY (B)(6) 2014. DURING A SUBSEQUENT SURGERY FOR A RUPTURED PERONEAL TENDON IN (B)(6) 2015, MY SURGEON, (B)(6), ALSO REPLACED THE PE MOBILE BEARING. ADVERSE EVENT: AT 8 PM MST ON (B)(6) 2021, I EXPERIENCED SPONTANEOUS, DEBILITATING, MESIAL PAIN IN MY (R) ANKLE. I COULD NOT BEAR WEIGHT WITHOUT EXCRUCIATING PAIN. UPON WAKING THE FOLLOWING MORNING, THE SYMPTOMS PERSISTED. SUSPECTING PE FRACTURE, I WENT TO THE (B)(6) AND OBTAINED X-RAY AND CT IMAGING. IMAGING DID NOT REVEAL THE SOURCE OF PAIN. CURRENTLY, I AM WAITING TO BE SCHEDULED FOR AN APPOINTMENT WITH (B)(6) FOR EVALUATION AND TREATMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581067 SCANDINAVIAN TOTAL ANKLE REPLACEMENT PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED NTG STRYKER GMBH STAR-PE-2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability