BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP INTERFSCRW W/DISP SHTH

    MDR report key: 8456852 · Received March 27, 2019

    Report

    Report Number
    1220246-2019-00987
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    January 9, 2019
    Report Date
    March 27, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867015272
    PMA / PMN Number
    K151342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE DEVICE REMAINS IN THE PATIENT. THE ROOT 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. PATIENT SENSITIVITY TO MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND A HALF AFTER HAVING A PRIMARY BTB ACL AUTOGRAFT PROCEDURE PERFORMED, THE PATIENT STARTED EXPERIENCING SWELLING OF THE HANDS, FEET, AND FACE WITH A REPORTED INCREASED LEVEL OF PAIN ON THE OPERATIVE KNEE. THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2019. THE REP CONFIRMED THERE ARE NO SIGNS OF INFECTION, AND NO SIGNS OF INCREASED SWELLING AROUND THE OPERATIVE KNEE. THE REP STATED THERE IS NOT A REVISION PROCEDURE SCHEDULED AT THIS TIME. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE ORIGINAL PROCEDURE, AND REMAIN IMPLANTED IN THE PATIENT: AR-1380C // LOT: 1023538 // QTY.: 1. AR-1380C // LOT: 1024227 // QTY.: 1. AR-2324BCC // LOT: 1020860 // QTY.: 1. ADDITIONAL INFORMATION RECEIVED ON 3/14/2019: THE FACILITY CONFIRMED THAT THE PATIENT IS NOT BEING TREATED WITH ANY MEDICATIONS AT THIS TIME. THE PATIENT WAS ADVISED BY THEIR PRIMARY PHYSICIAN TO MONITOR SYMPTOMS. THE FACILITY IS SENDING TO HAVE ALLERGY TESTING DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247887 BIO-COMP INTERFSCRW W/DISP SHTH FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH 1024227 00888867015272

    Patients

    Seq Age Sex Outcome Treatment
    1 Other