BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 11865609 · Received May 21, 2021

    Report

    Report Number
    3009351194-2021-00114
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    April 26, 2021
    Report Date
    November 24, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE RADIOGRAPHIC IMAGES WERE PROVIDED THAT DO SHOW THE THE PHALANX HAS DEVIATED DORSALLY AND THE DEVICE HAS LOOSENED RESULTING IN A DECREASED JOINT SPACE. HOWEVER, 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. REVIEW OF THE IMMEDIATE POST OP RADIOGRAPHIC IMAGES PROVIDED DID FIND THE SPACE WHERE THE CARTIVA IMPLANT IS, HAS SHARP ANGLES. THE AP-VIEW REVEALED THAT THE IMPLANT IS NOT PLACED IN THE CENTER, BUT SEEMS TO DEVIATE LATERALLY. THE OTHER VIEW SHOWS A GOOD POSITION. REVIEW OF 6 MONTHS POST OP RADIOGRAPHIC IMAGES FOUND THE ANGLES IN BOTH DIRECTIONS OF THE CUPS WHERE THE CARTIVA IMPLANT IS SITUATED SEEM TO BE ROUNDED, ESPECIALLY SEEN IN THE LATERAL VIEW. FURTHERMORE THE JOINT LOOKS ¿INSTABLE¿, THE PHALANX HAS DEVIATED DORSALLY. THIS IS CONFIRMED IN THE AP WHERE THE JOINT SPACE LOOKS SMALLER. IT CAN BE SPECULATED THE LOOSENING WAS A RESULT OF THE IMPLANT CUP BECOMING BIGGER AND DEEPER (ROUNDING OF THE EDGES). THIS CAN HAVE SEVERAL CAUSES, INFECTION OR INFLAMMATION (BIOCOMPATIBILITY). ANOTHER REASON FOR THE LOOSENING COULD BE TOO MUCH PRESSURE ON THE IMPLANT, CAUSING IT TO MOVE AND TRIGGER THE LOOSENING. 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. ACCORDING TO THE IFU, "1. RISKS ASSOCIATED WITH FOOT SURGICAL PROCEDURES INCLUDE: INFECTION, BLOOD CLOTS, BLOOD LOSS, DAMAGE TO ADJACENT NERVES, ARTERIES, OR VEINS, ANESTHESIA-RELATED PROBLEMS, ALLERGIC REACTION, NUMBNESS IN THE TOES, PAINFUL SCARS, PAIN WHEN WEARING SHOES OR WALKING, INCOMPLETE CORRECTION OF THE PROBLEM, RECURRENCE OF THE DEFORMITY, HEART ATTACK, STROKE, NERVE DAMAGE, DEEP VEIN THROMBOSIS (DVT), PULMONARY EMBOLUS (PE), AND DEATH. 2. RISKS ASSOCIATED WITH IMPLANTATION OF HEMI-ARTHROPLASTY DEVICES OR CARTIVA SYNTHETIC CARTILAGE IMPLANT INCLUDE INFECTION, INFLAMMATION, PAIN, SWELLING, EFFUSION, JOINT IRRITATION, FIBROSIS, JOINT INSTABILITY, JOINT MALALIGNMENT, PERIARTICULAR CYST, BONE CYST, BONE LOSS, SESAMOID BONE(S) IRRITATION, SESAMOID BONE(S) FRACTURE, METATARSAL BONE FRACTURE, OSTEONECROSIS, AVASCULAR NECROSIS, IMPLANT FRACTURE, IMPLANT LOOSENING, IMPLANT DISLOCATION, IMPLANT DISLODGEMENT, IMPLANT SUBSIDENCE, REVISION OR CONVERSION TO FUSION, ALLERGIC REACTION TO POLYVINYL ALCOHOL (PVA), PROGRESSIVE OSTEOARTHRITIS (OA), INCORRECT IMPLANT PLACEMENT, AND DAMAGE TO ADJACENT OR SURROUNDING TISSUES.¿ 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SURGEON THAT THE IMPLANT IS SINKING IN THE BONE. THE PATIENT CONTINUED TO HAVE PAIN. THE PATIENT UNDERWENT A REVISION SURGERY OF THE MTP JOINT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE IMPLANT IS SINKING IN THE BONE. THE PATIENT CONTINUED TO HAVE PAIN. THE PATIENT UNDERWENT A REVISION SURGERY OF THE MTP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763808 CARTIVA PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention