BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS

    MDR report key: 20426144 · Received October 11, 2024

    Report

    Report Number
    3010667733-2024-00719
    Event Type
    Death
    Date Received
    October 11, 2024
    Date of Event
    January 27, 2022
    Report Date
    December 23, 2024
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    PMA / PMN Number
    K191393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    AFTER A COMPLETE REVIEW OF THE DATA DURING INVESTIGATION, THE DEVICE CATALOG # 33680032 HAS BEEN DEEMED CONCOMITANT. THEREFORE, MFR REPORT # 3010667733-2024-00719 IS NO LONGER APPLICABLE AND THE RECORD WILL CANCELED.

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: (B)(6) INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2022: FLEXOR HALLUCIS LONGUS LACERATION. INTRA-OPERATIVE LACERATION. AFTER TIBIAL RESECTION COMPLETED AND TIBIAL RESECTION COMPLETED, FHL WAS NOTED TO HAVE SUSTAINED COMPLETE LACERATION AND WAS NOT REPAIRED. (B)(6) 2023: NO COMPLAINTS OR SYMPTOMS VOICED."

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: (B)(6) INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2) ON (B)(6) 2022: FLEXOR HALLUCIS LONGUS LACERATION. INTRA-OPERATIVE LACERATION. AFTER TIBIAL RESECTION COMPLETED AND TIBIAL RESECTION COMPLETED, FHL WAS NOTED TO HAVE SUSTAINED COMPLETE LACERATION AND WAS NOT REPAIRED. (B)(6) 2023: NO COMPLAINTS OR SYMPTOMS VOICED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301173 FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY, INC. 1719462

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other