BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX CHONDRAL DART, 18MM

    MDR report key: 7033765 · Received November 15, 2017

    Report

    Report Number
    1220246-2017-00439
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 15, 2017
    Manufacturer
    ARTHREX INC.
    Product Code
    MAI
    UDI-DI
    00888867031166
    PMA / PMN Number
    K082999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT PART REMAINED IN THE PATIENT AND CANNOT BE RETURNED THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. A POSSIBLE CAUSE OF THIS TYPE OF EVENT MAY BE A REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED OR USED DURING THE IMPLANT PROCEDURE. ALSO ANOTHER MANUFACTURER'S DEVICE WAS IMPLANTED AT THE SAME TIME WHICH MAY HAVE ALSO CONTRIBUTED TO THE PATIENT'S SITUATION. PRODUCT DIRECTIONS FOR USE WARNS OF EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (AR-1010-BC, BIOCARTILAGE, IS AN OEM DEVICE AND OEM VENDOR IS RESPONSIBLE FOR REGULATORY SUBMISSION FOR THIS PRODUCT. ARTHREX WILL FILE SUBMISSION FOR AR-127520 CHONDRAL DART -MEDWATCH 1220246-2017-00439.)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A RIGHT KNEE REPAIR ON (B)(6) THE PATIENT WAS DIAGNOSED WITH AN INFECTION. ADDITIONAL INFORMATION OBTAINED (B)(6) 2017: PROCEDURE WAS TO CORRECT A RIGHT OSTEOCHONDRAL DEFECT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2017 PROCEDURE: BIOCARTILAGE 1CC, ABS-1010-BC, LOT: 014075 (QTY1) (CC127520 LINE 210231) AND CHONDRAL DART 18MM, AR-4005B-18, LOT: E1616 (QTY 3) (CC127520 LINE 211573). ADDITIONAL INFORMATION OBTAINED (B)(6) 2017: TYPE OF SURGERY: RIGHT KNEE ARTHROSCOPY, DRILLING AND PINNING OF OSTEOCHONDRAL LESION, INSERTION OF BIOCARTILAGE TO FILL CARTILAGE GAP DUE TO OSTEOCHONDRAL LESION. HARVEST OF CARTILAGE FOR POTENTIAL MACI GRAFT IN FUTURE. OPEN EXCISION OF SYMPTOMATIC FRAGMENT OF TIBIAL TUBERCLE AS SEQUELA OF PREVIOUS OSGOOD-SCHLATTER DISEASE, THROUGH SEPARATE INCISION. SURGEON REPORTED THAT PATIENT WAS ADMITTED TO ANOTHER FACILITY ON (B)(6) 2017. ADDITIONAL INFORMATION OBTAINED (B)(6) 2017: PATIENT HAS BEEN EXPERIENCING A FEVER READING 103 WITH ELEVATED PAIN AND SWELLING WHICH BEGAN 3 DAYS POST OP. PATIENT IS (B)(6) FROM KNEE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812103 ARTHREX CHONDRAL DART, 18MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX INC. E1616 00888867031166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other