BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN TAR IMPLANT

    MDR report key: 22078116 · Received May 23, 2025

    Report

    Report Number
    3010667733-2025-00646
    Event Type
    Death
    Date Received
    May 23, 2025
    Date of Event
    April 28, 2025
    Report Date
    July 22, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION - PLEASE REFER H6 DEVICE CODE. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO OTHER EVIDENCE WAS 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 WAS NOT POSSIBLE BECAUSE THE CATALOG NUMBER AND LOT NUMBER WERE NOT COMMUNICATED. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE CATALOG NUMBER AND LOT NUMBER WERE NOT COMMUNICATED. HOWEVER, FAILURE OF TOTAL ANKLE REPLACEMENT TAR OVER TIME IS A KNOWN COMPLICATION. IN CASE OF A PLANNED REVISION PROCEDURE, A MEDICAL OPINION AIMING TO DETERMINE THE ROOT CAUSE OF THE FAILURE IS PART OF THE INTERNAL INVESTIGATION PROCESS. SUFFICIENT RADIOLOGICAL AND CLINICAL INFORMATION MUST BE PROVIDED TO ENABLE A MEANINGFUL CLINICAL ASSESSMENT AND TO IDENTIFY POSSIBLE CAUSES OF FAILURE. IN CASES WHERE A CT SCAN IS THE ONLY AVAILABLE CLINICAL SOURCE, THIS ASSESSMENT IS LIMITED. NO CONCLUSIVE STATEMENT CAN BE PROVIDED, BECAUSE KEY CLINICAL INFORMATION E.G. CLINICAL STATUS, EXACT SYMPTOMS AND RANGE OF MOTION OF THE PATIENT, ASSESSMENT OF THE TREATING PHYSICIAN IS MISSING. THE ROOT CAUSES OF RADIOGRAPHIC FINDINGS SUCH AS RADIOLUCENT AREAS AND BONE CYSTS ARE OFTEN COMPLEX AND MULTIFACTORIAL AND CANNOT BE DETERMINED SCIENTIFICALLY WITHOUT THIS DECISIVE EVIDENCE. DUE TO THESE LIMITATIONS, WE ARE UNABLE IN SUCH CASES TO PROVIDE STATEMENTS ABOUT THE PATIENT, THE PROCEDURE AND OR THE DEVICE IN RELATION TO CAUSE OF THE FAILURE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE 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 TAR FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS 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 TAR FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961478 UNKNOWN TAR IMPLANT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention