BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL AP HUMERAL STEM 6MM

    MDR report key: 2232226 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15355
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWS
    PMA / PMN Number
    K060874
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REVIEW OF THE AS400 SYSTEM SHOW THAT 13 OTHER DEVICES FROM THE REPORTED LOT HAVE BEEN DELIVERED AND/OR INVOICED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE AS NO FURTHER REPORTS ARE IDENTIFIED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR LOOSE HUMERAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL AP HUMERAL STEM 6MM 87KWS, HSD KWS DEPUY ORTHOPAEDICS, INC. NA C13J51000

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention