BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A. S. HUMERAL STEM 14 UNCEMENTED

    MDR report key: 3233887 · Received July 16, 2013

    Report

    Report Number
    9613350-2013-01733
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 5, 2013
    Manufacturer
    ZIMMER
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. THE PRODUCT HAS BEEN RECEIVED FOR INVESTIGATION. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, ONCE THE RESULT OF THE INVESTIGATION HAS BEEN MADE AVAILABLE, THE FINAL REPORT WILL BE ADMITTED. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER FOLLOWING ALL SURGICAL INSTRUCTIONS, THE STEM DID NOT FIT INTO THE HEAD. "THE ANATOMICAL SHOULDER HUMERAL STEM, SIZE 14 COULD NOT BE IMPLANTED INTO THE HUMERAL HEAD 52/19, RASP 14 WAS USED. AFTER A HEAD 52/53 WAS USED AND PUT IN THE RIGHT POSITION WITH THE RASP. THE STEM, SIZE 14 COULD NOT BE IMPLANTED. A STEM WITH THE SIZE 12 WAS THEN IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328132 A. S. HUMERAL STEM 14 UNCEMENTED ANATOMICAL SHOULDER WITH REMOVABLE HEAD HSD ZIMMER 2470311

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R