BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL APEX HUMERAL STEM, 6 MM

    MDR report key: 6661143 · Received June 22, 2017

    Report

    Report Number
    1220246-2017-00222
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 22, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867134416
    PMA / PMN Number
    K131633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. 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. THIS IS ONE OF THREE SUBMISSIONS FOR THE SAME PATIENT EVENT. THE OTHERS ARE 1220246-2017-00223 ((B)(4)) AND 1220246-2017-00224 ((B)(4)). THE EVALUATION REVEALED DENTS AND SCRATCHES ON THE INCLINATION BLOCK, STEM, AND TRUNNION. THE DAMAGES OBSERVED ON THE SURFACES WERE MOST LIKELY CAUSED DURING THE EXTRACTION OF THE IMPLANT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2014. IN (B)(6) 2014, THE PATIENT BEGAN TO EXPERIENCE LAXITY IN THE SHOULDER. ON (B)(6) 2017, A REVISION REVERS TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED WHERE THE PREVIOUSLY IMPLANTED UNIVERS APEX 6MM HUMERAL STEM (AR-9100-06S, LOT: 974810, LINE 195553), SMALL GLENOID W/ PEG (AR-9105-01, LOT: 1329015, (B)(4)) AND USP II HUMERAL HEAD (AR-9144-17P, LOT: 2501356510, (B)(4)) WERE EXPLANTED AND REPLACED WITH ARTHREX REVERS TOTAL SHOULDER PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441302 UNIVERSAL APEX HUMERAL STEM, 6 MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. 974810 00888867134416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other