BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS HUMERAL HEAD 46/17

    MDR report key: 5666121 · Received May 19, 2016

    Report

    Report Number
    1220246-2016-00225
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    April 7, 2016
    Report Date
    July 1, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K010124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE ORIGINAL DEVICES WERE IMPLANTED 10 YEARS PRIOR TO THE REVISION SURGERY. ONE AR-9146-17 ASSEMBLY WAS RETURNED FOR EVALUATION. NO VISUAL ANOMALIES FOUND ON THE AR-9146-17 HUMERAL HEAD, HOWEVER, COMPLAINT CONFIRMED ON THE CAGE SCREW (PART OF THE HUMERAL HEAD ASSEMBLY) WHICH WAS FRACTURED (BROKE IN HALF). A MOST LIKELY CAUSE OF THIS EVENT IS THAT THE PATIENT MAY HAVE EXPERIENCED UNREPORTED TRAUMA/INJURY TO THE SHOULDER. 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.

    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 REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. 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 TRUNION AND THE GLENOIDAL CAGE SCREW (WHICH ARE ASSEMBLED TO THE STEM) HAD BROKEN-OFF FROM THE STEM, AR-9100-09. ACCORDING TO THE REPORT, NO TRAUMA HAPPENED. FOLLOW-UP INVESTIGATION: UNIVERS 3D WAS INITIALLY IMPLANTED ON (B)(6) 2006, REVISION WAS PERFORMED ON (B)(6) 2016 DUE TO IMPLANT COMPONENT (CAGE SCREW) BREAKAGE. PATIENT RECEIVED ANOTHER MANUFACTURER'S CEMENTED SHAFT, LONG, SIZE 1/DIAMETER 8 WITH CTA HEAD 48MM X 21MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRUNION AND THE GLENOIDAL CAGE SCREW (WHICH ARE ASSEMBLED TO THE STEM) HAD BROKEN-OFF FROM THE STEM, AR-9100-09. ACCORDING TO THE REPORT, NO TRAUMA HAPPENED. FOLLOW-UP INVESTIGATION: UNIVERS 3D WAS INITIALLY IMPLANTED ON (B)(6) 2006, REVISION WAS PERFORMED ON (B)(6) 2016 DUE TO IMPLANT COMPONENT (CAGE SCREW) BREAKAGE. PATIENT RECEIVED ANOTHER MANUFACTURER'S CEMENTED SHAFT, LONG, SIZE 1/DIAMETER 8 WITH CTA HEAD 48MM X 21MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320470 UNIVERS HUMERAL HEAD 46/17 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. 04090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other