BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS HUMERAL HEAD FX RIGHT 48

    MDR report key: 1192463 · Received October 9, 2008

    Report

    Report Number
    9613350-2008-00154
    Event Type
    Injury
    Date Received
    October 9, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ORIGINAL STEM, BASEPLATE AND HEAD FROM PREVIOUS SURGERY CAME OUT WHEN ATTEMPTING TO REMOVE THE HEAD ONLY. REVISION OF THE ANATOMIC FX STEM- SUBSIDED AND DISLOCATED. ATTEMPTED TO REMOVE 44R HEAD AND STEM CAME OUT ALSO. COULD NOT REMOVE HEAD ON BACK TABLE. DOCTOR DECIDED TO GO TO 12 STEM CEMENTED AND 48R HEAD. HUMERUS WAS THEN BROKEN. AT THIS POINT DECISION WAS MADE TO USE LONG (200 MM) 11 STEM. DOCTOR WANTED TO USE EITHER 44 OR 48 HEAD THAT WERE ON THE FIELD BUT UNABLE TO DISENGAGE EITHER ONE. CEMENTED IN 11X200 MM AND 44R HEAD. WASTED 12 STEM AND 48R HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS HUMERAL HEAD FX RIGHT 48 ANATOMICAL SHOULDER INVERSE/REVERSE HSD ZIMMER GMBH 2380525

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R