BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TALAR COMPONENT

    MDR report key: 19632814 · Received June 28, 2024

    Report

    Report Number
    3010667733-2024-00396
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 3, 2024
    Report Date
    September 18, 2024
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. UPON FURTHER INVESTIGATION OF THE CT SCANS, HEALTHCARE PROFESSIONALS OPINED THAT- ¿THERE IS NOT REAL CLINICAL INFORMATION GIVEN IN THIS CASE. HOWEVER, THERE ARE LARGE CYSTS AND RADIOLUCENCE AND THE TALAR COMPONENT SEEMS TO BE SUBSIDED. THAT WOULD EXPLAIN THE SURGEONS NOTE, THAT HE IS GOING TO REVISE THE TALUS. FROM THE TIBIA NO MORPHOLOGICAL PROOF IS GIVEN, THAT THERE IS LOOSENING OR MIGRATION. THERE IS NO INFORMATION GIVEN OR ASSESSMENT POSSIBLE REGARDING THE UNDERLYING CAUSE OF FOR THE REVISION. POOR BONE SUBSTANCE AND THUS A PATIENT RELATED FACTOR IS LIKELY. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO PATIENT RELATED ISSUE. THE EVENT WAS MOST LIKELY CAUSED BY THE PRESENCE OF POOR BONE SUBSTANCE WHICH CAUSED THE IMPLANT FAILURE.¿ IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    HE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TALAR COMPONENT FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PHYSICIAN MAY ADD A SUBTALAR FUSION DEPENDING ON WHAT IS LEFT OF THE JOINT.

    Description of Event or Problem · 0

    THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TALAR COMPONENT FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PHYSICIAN MAY ADD A SUBTALAR FUSION DEPENDING ON WHAT IS LEFT OF THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827862 UNKNOWN TALAR COMPONENT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other