BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA DEVICE 10MM T20-0388

    MDR report key: 21692392 · Received March 25, 2025

    Report

    Report Number
    3009351194-2025-00155
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    March 7, 2025
    Report Date
    May 28, 2025
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. 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. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY CONTACTED STRYKER WITH THE FOLLOWING PRODUCT LIABILITY CLAIM: "ON (B)(6) 2022, DR. (B)(6) FROM (B)(6), INSERTED A ¿CARTIVA IMPLANT¿ WITH A DIAMETER OF 10 MM, (B)(4) FROM STRYKER INTO OUR CLIENT'S LEFT BIG TOE AS PART OF A HALLUX RIGIDUS SURGERY. THE SURGERY WAS PERFORMED AT THE (B)(6). AS A RESULT, THE PATIENT EXPERIENCED SEVERE MOVEMENT IMPAIRMENTS AND PAIN, SO THAT A REVISION OPERATION HAD TO BE PERFORMED ON (B)(6) 2022. THE CARTIVA IMPLANT WAS REMOVED, AND A STIFFENING WAS PERFORMED. - REPORTED UNDER MANUFACTURER REPORT (B)(4). THE REVISION SURGERY AND THE BONE DEFECT THAT OCCURRED, INCLUDING THE PAIN AND IMPAIRED MOBILITY, CAN BE ATTRIBUTED TO A PRODUCT DEFECT IN THE CARTIVA IMPLANT. TO THIS DAY, OUR CLIENT SUFFERS MASSIVELY FROM THE IMPAIRMENTS AND SUBSEQUENT COMPLAINTS. IN THE MEANTIME, THE PATIENT HAS HAD TO UNDERGO A THIRD OPERATION. A FOURTH OPERATION IS PLANNED. IT IS CURRENTLY NOT POSSIBLE TO PREDICT HOW OUR CLIENT'S HEALTH WILL DEVELOP. THE PERMANENT PAIN AND MOVEMENT RESTRICTIONS ARE ALSO CAUSING OUR CLIENT CONSIDERABLE PSYCHOLOGICAL STRAIN."

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY CONTACTED STRYKER WITH THE FOLLOWING PRODUCT LIABILITY CLAIM: "ON (B)(6) 2022, DR. (B)(6), INSERTED A ¿CARTIVA IMPLANT¿ WITH A DIAMETER OF 10 MM, CAR-10, GTIN (B)(4) FROM STRYKER INTO OUR CLIENT'S LEFT BIG TOE AS PART OF A HALLUX RIGIDUS SURGERY. THE SURGERY WAS PERFORMED AT THE (B)(6). AS A RESULT, THE PATIENT EXPERIENCED SEVERE MOVEMENT IMPAIRMENTS AND PAIN, SO THAT A REVISION OPERATION HAD TO BE PERFORMED ON (B)(6) 2022. THE CARTIVA IMPLANT WAS REMOVED, AND A STIFFENING WAS PERFORMED. - REPORTED UNDER MANUFACTURER REPORT (B)(4). THE REVISION SURGERY AND THE BONE DEFECT THAT OCCURRED, INCLUDING THE PAIN AND IMPAIRED MOBILITY, CAN BE ATTRIBUTED TO A PRODUCT DEFECT IN THE CARTIVA IMPLANT. TO THIS DAY, OUR CLIENT SUFFERS MASSIVELY FROM THE IMPAIRMENTS AND SUBSEQUENT COMPLAINTS. IN THE MEANTIME, THE PATIENT HAS HAD TO UNDERGO A THIRD OPERATION. A FOURTH OPERATION IS PLANNED. IT IS CURRENTLY NOT POSSIBLE TO PREDICT HOW OUR CLIENT'S HEALTH WILL DEVELOP. THE PERMANENT PAIN AND MOVEMENT RESTRICTIONS ARE ALSO CAUSING OUR CLIENT CONSIDERABLE PSYCHOLOGICAL STRAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099816 CARTIVA DEVICE 10MM T20-0388 PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Disability| R