BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA DEVICE 10MM T20-0388

    MDR report key: 17790073 · Received September 21, 2023

    Report

    Report Number
    3009351194-2023-00017
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    July 6, 2017
    Report Date
    December 19, 2023
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT (IMPLANT - LOOSENING POSTOPERATIVE) COULD BE CONFIRMED, SINCE REVIEW OF MEDICAL RECORDS PROVIDED DID FIND THE TREATING SURGEON CONFIRMED THE IMPLANT HAD SUBSIDED. ALTHOUGH MEDICAL RECORDS PROVIDED WERE ABLE TO CONFIRM THE ALLEGATION OF IMPLANT SUBSIDENCE, NO DEFINITIVE ROOT CAUSES COULD BE EXTRACTED FROM THESE DOCUMENTS. THE PATIENT HAD A HISTORY OF PROCEDURES PERFORMED AT THE IMPLANT SITE AND SURROUNDING ANATOMY. THERE WAS ALSO A PATIENT FALL NOTED PRIOR TO THE PATIENT'S FIRST REVISION SURGERY OF THE SCREWS AND STAPLES. IT WAS NOTED THAT THE PATIENT'S POSTOPERATIVE HEALING PROCESS AFTER IMPLANT WAS UNREMARKABLE UNTIL THE IMPACT TRAUMA. MEDICAL AFFAIRS WAS ALSO CONSULTED ON THE DETAILS OF THIS CASE. ACCORDING TO THEIR REVIEW, "THE DOCUMENTATION OF THE SURGEONS AND THE INVOLVED MEDICAL HEALTH CARE PERSONNEL IS PRETTY COMPREHENSIVE, BUT I DID NOT REVEAL ANYTHING WHICH COULD HELP IDENTIFY A SPECIFIC CAUSE FOR THE FAILURE." 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 FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. 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. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 0

    THE CLAIMANT WAS IMPLANTED WITH THE CARTIVA IMPLANT. IT WAS FOUND THAT THE IMPLANT HAD SUBSIDED 3 YEARS POST-OP, CAUSING THE CLAIMANT PAIN AND DISCOMFORT, AS WELL AS CAUSING HER TO HAVE TO UNDERGO FURTHER REMEDIAL PROCEDURES.

    Description of Event or Problem · 0

    THE CLAIMANT WAS IMPLANTED WITH THE CARTIVA IMPLANT. IT WAS FOUND THAT THE IMPLANT HAD SUBSIDED 3 YEARS POST-OP, CAUSING THE CLAIMANT PAIN AND DISCOMFORT, AS WELL AS CAUSING HER TO HAVE TO UNDERGO FURTHER REMEDIAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061536 CARTIVA DEVICE 10MM T20-0388 PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC F033016001

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other