BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, PE WITH PEG, MEDIUM

    MDR report key: 5439357 · Received February 16, 2016

    Report

    Report Number
    1220246-2016-00094
    Event Type
    Injury
    Date Received
    February 16, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 19, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. THIS IS ONE OF THREE SUBMISSIONS FROM THE SAME EVENT. THE OTHER TWO SUBMISSIONS ARE 1220246-2016-00033- LINE 151395 AND 1220246-2016-00093-LINE 151394. 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. THE EXPLANTED DEVICES WERE REQUESTED FOR EVALUATION BUT WERE NOT RETURNED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE FOR THE REVISION SURGERY IS AS STATED IN THE EVENT THAT THE PATIENT WAS REPORTED TO HAVE FALLEN POST-OP AND TORE HER ROTATOR CUFF. THE DIRECTIONS FOR USE STATES: POST-OPERATIVELY, UNTIL HEALING IS COMPLETE THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POST-OPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE IMPLANT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. FACILITY WILL NOT RETURN THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A RIGHT UNIVERS II IMPLANTED DURING A (B)(6) 2014 PROCEDURE. PATIENT WAS REPORTED TO HAVE FALLEN POST-OP AND TORE HER ROTATOR CUFF. ON (B)(6) 2016 PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE ORIGINAL ARTHREX DEVICES WERE EXPLANTED AND ANOTHER MANUFACTURER'S DEVICE IMPLANTED. EXPLANTED DEVICES NOT AVAILABLE FOR EVALUATION. PARTS GIVEN TO THE PATIENT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95713 GLENOID, PE WITH PEG, MEDIUM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. 13160412501228507

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other