BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE PC STEM 8MM

    MDR report key: 1984496 · Received January 28, 2011

    Report

    Report Number
    1818910-2011-01314
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MBF
    PMA / PMN Number
    K011047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE HEAD PART AND LOT NUMBER COMBINATION. A SEARCH OF THE COMPLAINT DATABASE FOUND ONE PRIOR REPORT FOR THE STEM PART AND LOT NUMBER COMBINATION; HOWEVER, REVIEW OF THE AS400 SYSTEM SHOW THAT 12 OTHER DEVICES FROM THE STEM REPORTED LOT HAVE BEEN DELIVERED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE. 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 INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS SHOULDER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE PC STEM 8MM 87MBF; 87KWS MBF DEPUY ORTHOPAEDICS, INC. NA C5AB61000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention