BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ADAPTIS TIB SZ3LNG INFINITY ADAPTIS

    MDR report key: 20426080 · Received October 11, 2024

    Report

    Report Number
    3010667733-2024-00718
    Event Type
    Injury
    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
    K181557
    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

    THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON AVAILABLE INFORMATION. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: 200-016 INFINITY¿ WITH ADAPTIS¿ TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). 27 JAN 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. 18 JAN 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) (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
    313622 INFINITY ADAPTIS TIB SZ3LNG INFINITY ADAPTIS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY, INC. 1716255

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other