BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_CARTIVA IMPLANT

    MDR report key: 22793127 · Received August 13, 2025

    Report

    Report Number
    3010667733-2025-00912
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 13, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    PNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1177/24730114251343071. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE DEPARTMENT OF ORTHOPAEDICS, UNIVERSITY OF SAN DIEGO SCHOOL OF MEDICINE. THE TITLE OF THIS REPORT IS ¿¿MEDIAL SESAMOIDECTOMY AS A LOCAL AUTOGRAFT SOURCE IN REVISION OR COMPLEX FIRST METATARSOPHALANGEAL JOINT ARTHRODESIS", PUBLISHED ON 16 JUNE 2025, WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA IMPLANT SYSTEM. THE ARTICLE CAN BE FOUND ON HTTPS://DOI.ORG/10.1177/24730114251343071 THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON X PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM 2021 TO 2023. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT: 3 PATIENTS HAD POSTOPERATIVE SUPERFICIAL WOUND INFECTIONS MANAGED WITH ORAL ANTIBIOTICS" THIS IS 2 OUT OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763162 UNK_CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention