BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FW,BPB #2 SUTR,BLU W/NDL

    MDR report key: 8649296 · Received May 29, 2019

    Report

    Report Number
    1220246-2019-01114
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041264
    PMA / PMN Number
    K122374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    501

    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. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER HAVING A PRIMARY TOTAL SHOULDER PROCEDURE, THE PATIENT STARTED EXPERIENCING PAIN AND DISCOMFORT INSIDE THE JOINT AND CAPSULE. THE REP STATED IT IS UNKNOWN THE DATE OF THE ORIGINAL PROCEDURE AND THE SPECIFIC ARTHREX PART NUMBERS THAT WERE ORIGINALLY IMPLANTED. THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2019. DURING THE REVISION PROCEDURE, THE SURGEON EXAMINED THE HUMERAL JOINT AND CONSTRUCT TO DETERMINE IF THE CAUSE OF PAIN WAS DUE TO LOOSENING COMPONENTS. THE CONSTRUCT WAS CONFIRMED STABLE AND SECURE. THE SURGEON THEN TOOK JOINT FLUID AND TISSUE SAMPLES TO HAVE CULTURE TESTING DONE TO CONFIRM IF INFECTION OR REACTION COULD BE THE CAUSE OF THE PAIN. THE SURGEON DECIDED TO REMOVE THE IMPLANTED AR-7200 FIBERWIRE TO RULE OUT ANY POTENTIAL ISSUE. THE REP CONFIRMED ONLY THE AR-7200 WAS EXPLANTED DURING THE REVISION PROCEDURE. THE REP STATED THE RESULTS OF THE CULTURE TESTING ARE NOT KNOWN AT THIS POINT IN TIME. ADDITIONAL INFORMATION RECEIVED ON 05/28/2019: THE ORIGINAL PROCEDURE WAS AN ANATOMIC TOTAL SHOULDER ARTHROPLASTY THAT TOOK PLACE ON (B)(6) 2016. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE ORIGINAL PROCEDURE: AR-7200/LOT: UNKNOWN. THE ORIGINAL AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON, AT THE SAME FACILITY. THE PATIENT STARTED EXPERIENCING PAIN AND DISCOMFORT SIX MONTHS AFTER THE PRIMARY PROCEDURE. THE PATIENT WAS GOING THROUGH PHYSICAL THERAPY TO HELP WITH THEIR PAIN SYMPTOMS. CULTURES WERE TAKEN BEFORE THE REVISION AND DURING REVISION. THE PATIENT DID NOT TEST POSITIVE FOR ANYTHING TESTED DURING THE REVISION. HOWEVER, P. ACNES WAS FOUND FROM THE PRIOR ASPIRATION CULTURE THAT WAS TAKEN FROM THE INCISION SITE. THERE WERE NOT ANY ADDITIONAL ARTHREX PARTS IMPLANTED DURING THE REVISION PROCEDURE. THE EXPLANTED AR-7200 WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442518 FW,BPB #2 SUTR,BLU W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL UNK 00888867041264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other