BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS II HUMERAL HEAD 56/24

    MDR report key: 2872313 · Received December 13, 2012

    Report

    Report Number
    1220246-2012-00247
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K071032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, 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. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED ONLY SUPERFICIAL SCRATCHES TO THE POLISHED ARTICULATING SURFACE. DIMENSIONAL ANALYSIS OF THE HUMERAL HEAD AND ACCOMPANYING TRUNION WAS VERIFIED TO MEET SPECIFICATIONS. NO PROBLEMS WERE FOUND WITH THE DEVICE. THE PATIENT STATED HE HAD TRIED TO WORKOUT. THE MOST LIKELY CAUSE OF THIS EVENT IS FAILURE TO FOLLOW THE POST-OP REHAB PROTOCOL. THE DIRECTIONS FOR USE STATES: POSTOPERATIVELY, UNTIL HEALING IS COMPLETE THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POSTOPERATIVE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN AND HIS SHOULDER HAD "LOCKED UP". X-RAYS SHOWED HE HAD DISLOCATED HIS SHOULDER ABOUT 3 WEEKS AFTER SURGERY. THE HUMERAL STEM AND ALL OF ITS COMPONENTS WERE INTACT. THE HEAD HAD COME LOOSE FROM THE TRUNION AND HE HAD PULLED THE SUBSCAPULAR AWAY FROM THE PRIMARY MUSCLE. THE HEAD WAS REPLACED. PATIENT STATED HE HAD TRIED TO WORKOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERS II HUMERAL HEAD 56/24 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. 2501119100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other