BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS II HUMERAL STEM 10MM

    MDR report key: 2295916 · Received October 14, 2011

    Report

    Report Number
    1220246-2011-00166
    Event Type
    Injury
    Date Received
    October 14, 2011
    Date of Event
    September 20, 2011
    Report Date
    September 20, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K071032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    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 REVEALED NOTHING RELEVANT TO THIS EVENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED; THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE SURGEON CHOSE TO DOWNSIZE THE REPLACEMENT DEVICES USING A HEAD THAT WAS 4 SIZES SMALLER TOGETHER WITH A STEM 1 SIZE DOWN. BASED ON THE AVAILABLE INFORMATION AND WITHOUT DEVICE EVALUATION, THE CAUSE FOR THIS REVISION REMAINS UNDETERMINED. 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. CUSTOMER WILL NOT RELEASE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN ORIGINAL PROCEDURE FROM 2009. REVISION WAS DUE TO THE PATIENT HAVING PAIN AND AN X-RAY SHOWED THE STEM WAS LOOSE. AN AR-9100-10P HUMERAL STEM (LOT #0810902) & AR-9152-20P HUMERAL HEAD (LOT # 0800602) WERE REMOVED. SMALL PIECES OF BONE WERE CHIPPED AWAY IN ORDER TO REMOVE DEVICE. EVEN THOUGH IT WAS REPORTED THAT THE STEM WAS LOOSE, WHEN USING THE SLAP HAMMER AND BALL CONNECTION TOOLS TO REMOVE IT, TWO SLAP HAMMERS BROKE. CULTURES WERE TAKEN, NO INFECTION WAS FOUND. AN AR-9100-9P STEM & AN AR-9148-19P HEAD REPLACEMENTS WERE CEMENTED IN PLACE. DEVICES CANNOT BE RETURNED DUE TO HOSPITAL POLICY, THEY MUST GO TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERS II HUMERAL STEM 10MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. 0810902

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other AR-9201-14 LOT 1498022600| AR-9152-20P LOT 0800602