BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERUS GSB-III 76

    MDR report key: 2091455 · Received May 4, 2011

    Report

    Report Number
    9613350-2011-00296
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN (B)(4). THE MFR DID NOT YET RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS WE RECEIVE THE PRODUCTS AND A PRODUCT INVESTIGATION RESULT IS AVAILABLE, A F/U REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT WAS NOT ABLE TO FLEX THE ELBOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERUS GSB-III 76 GSB ELBOW JDC ZIMMER GMBH 2485456

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization