BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 11279573 · Received February 4, 2021

    Report

    Report Number
    3009351194-2021-00087
    Event Type
    Injury
    Date Received
    February 4, 2021
    Report Date
    January 6, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: AKOH ET AL. ADVERSE EVENTS INVOLVING HALLUX METATARSOPHALANGEAL JOINT IMPLANTS: COMPREHENSIVE ANALYSIS OF US FOOD AND DRUG ADMINISTRATION DATA FROM 2010 TO 2018. FOOT & ANKLE ORTHOPAEDICS. 2020; 5:4. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ARTICLE BY AKOH ET. AL. IN AN ARTICLE TITLED, "ADVERSE EVENTS INVOLVING HALLUX METATARSOPHALANGEAL JOINT IMPLANTS: COMPREHENSIVE ANALYSIS OF US FOOD AND DRUG ADMINISTRATION DATA FROM 2010 TO 2018" THE AUTHOR DID A REVIEW OF THE US FOOD AND DRUG ADMINISTRATION'S (FDA) MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE FROM 2010-2018 TO DETERMINE REPORTED ADVERSE EVENTS FOR HALLUX MTPJ ARTHROPLASTY. AMONG 64 UNIQUE HALLUX MTPJ IMPLANT ADVERSE EVENTS, THE MOST COMMON MODES OF FAILURE WERE COMPONENT LOOSENING (34%), COMPONENT FRACTURE (9.4%), INFLAMMATION (9.4%), INFECTION (14.1%), AND ALLERGIC REACTION (7.8%). IN REGARDS TO IMPLANT TYPE, SYNTHETIC IMPLANTS (CARTIVA) HAD THE HIGHEST PERCENTAGE OF ADVERSE EVENTS (23.4%), FOLLOWED BY ARTHROSURFACE TOEMOTION (20.3%), ASCENSION MGT (12.5%), ARTHROSURFACE HEMICAP (10.9%), FUTURA PRIMUS (9.4%), AND OSTEOMED REFLEXION (6.3%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175787 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R