BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMPOSITE SWIVELOCK CLD 4.75X19.1MM

    MDR report key: 7205653 · Received January 19, 2018

    Report

    Report Number
    1220246-2018-00007
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 20, 2017
    Report Date
    January 19, 2018
    Manufacturer
    ARTHREX INC.
    Product Code
    MAI
    UDI-DI
    00888867026827
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THE EVENT. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2017 THAT THE PATIENT UNDERWENT AN ANTERIOR LATERAL LIGAMENT RECONSTRUCTION APROX 6 WEEKS PRIOR WHERE AN ARTHREX SCREW (PART NUMBER UNKNOWN ) WAS IMPLANTED. ABOUT 36 HOURS POST-OP, THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT THAT SHE COULD NOT MANAGE WITH PAIN MEDICATION. THE PATIENT HAD X-RAYS TAKEN WHICH CONFIRMED THAT THE SCREW HAD BACKED OUT AND WAS NO LONGER FULLY SEATED, CREATING A GOOSE EGG EFFECT OVER THE LATERAL ASPECT. A REVISION SURGERY WAS PERFORMED AT THE SAME FACILITY WITH THE SAME SURGEON ON (B)(6) 2017. THE SCREW WAS EXPLANTED AND REPLACED WITH A BUTTON FROM AN UNKNOWN MANUFACTURER (COULD BE ARTHREX). PATIENT IS A FEMALE, (B)(6) WITH A HEIGHT OF 5'3 AND A WEIGHT OF (B)(6) LBS; DOB: (B)(6). FOLLOW-UP INVESTIGATION: ORIGINAL IMPLANTATION PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH THE FOLLOWING ARTHREX BIO-COMPOSITE SWIVELOCK ANCHOR WAS IMPLANTED: AR-2324BCC, LOT F161259. THE IMPLANT HAD BACKED OUT OF THE BONE HOLE AND WAS PRESSING ON THE UNDERSIDE OF THE PATIENT'S IT BAND. SINCE THE REVISION SURGERY, WHERE A BUTTON WAS IMPLANTED, THE PATIENT HAS BEEN EXPERIENCING LOCALIZED SWELLING AT THE SURGICAL SITE WITH APPROXIMATELY A PLUM SIZED LUMP/SWELLING. THERE HAS BEEN NO POSITIVE TESTS FOR INFECTIONS. MOST RECENT FOLLOW UP WITH SURGEON DISCUSSED A DISTINCT PROBABILITY THAT THE CURRENT IMPLANT WILL ALSO NEED TO BE REMOVED RESULTING IN A SECOND REVISION. REVISION HAS NOT YET BEEN PLANNED. PATIENT IS AN ORTHOPEDIC SURGEON SPECIALIZING IN SPORTS MEDICINE AND IS ALSO A TRI-ATHLETE. THE PROBLEMS SINCE HER INITIAL SURGERY HAVE CAUSED HER AN INABILITY TO COMPETE/WORK OUT AND HAS ALSO PREVENTED HER FROM PRACTICING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51884 BIO-COMPOSITE SWIVELOCK CLD 4.75X19.1MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX INC. F161259 00888867026827

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other