BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA DEVICE 10MM T20-0388

    MDR report key: 16513537 · Received March 9, 2023

    Report

    Report Number
    3009351194-2023-00009
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 8, 2023
    Report Date
    May 22, 2023
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED A CARTIVA DEVICE HAD TO BE REMOVED. EXCESSIVE WEAR OF THE IMPLANT WAS DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED A CARTIVA DEVICE HAD TO BE REMOVED. EXCESSIVE WEAR OF THE IMPLANT WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660108 CARTIVA DEVICE 10MM T20-0388 PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC F082720004

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention