BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS HUMERAL HEAD FX RIGHT 44

    MDR report key: 2101493 · Received May 17, 2011

    Report

    Report Number
    9613350-2011-00312
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 17, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED BY MR (B)(6), WHO IS WORKING AS A (B)(6) IN (B)(6). THE MANUFACTURER DID NOT RECEIVE FURTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WITH THE INFORMATION PROVIDED, THE ROOT CAUSE FOR THE ALLEGED EVENT CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE AND/OR THE DEVICES PACKAGING BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGERY WAS PROLONGATED BY 55 MINUTES BECAUSE A PART (HEAD) WAS MISSING IN THE PACKAGE AND A NEW COMPLETE SYSTEM HAD TO BE DELIVERED IN ORDER TO COMPLETE THE SURGERY. THIS INCIDENT HAPPENED DURING SURGERY. THIS COMPLAINT IS RELATED TO THE AS (B)(6) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS HUMERAL HEAD FX RIGHT 44 AMATOMICAL SHOULDER WITH REMOVABLE HEAD HSD ZIMMER GMBH 2563188

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other