BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ADAPTIS TIB SZ5LNG INFINITY ADAPTIS

    MDR report key: 20550176 · Received October 28, 2024

    Report

    Report Number
    3010667733-2024-00801
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 2, 2024
    Report Date
    January 15, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797069700
    PMA / PMN Number
    K181557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD BE CONFIRMED, SINCE THE INFORMATION FOR EVALUATION MATCHES THE ALLEGED FAILURE. UPON FURTHER INVESTIGATION OF THE CT SCANS BY HEALTHCARE PROFESSIONALS THE FOLLOWING WAS OBSERVED: THE CT SCAN OF THE CASE SHOWS A LARGE CYST AT THE TIBIAL STEM. LOOSENING AND SOME SUBSIDENCE TIBIALLY CAN BE CONFIRMED WITH THE PROVIDED CT SCAN. THERE IS NO REAL CLINICAL INFORMATION GIVEN AND THUS IT IS DIFFICULT TO SPECULATE ABOUT THE UNDERLYING CAUSE OF THE LOOSENING. 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. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    THE 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 DUE TO PAIN AND LOOSE TIBIAL TRAY.

    Description of Event or Problem · 0

    THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND LOOSE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923285 INFINITY ADAPTIS TIB SZ5LNG INFINITY ADAPTIS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN 00889797069700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other