BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM STD 36+12L 15X20

    MDR report key: 2894052 · Received January 3, 2013

    Report

    Report Number
    1818910-2013-10092
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    October 9, 2012
    Report Date
    December 10, 2012
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    MRA
    PMA / PMN Number
    PP040023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES A REVISION DUE TO ASEPTIC LOOSENING OF THE STEM AN SLEEVE, PAIN, AND STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3623 SROM STM STD 36+12L 15X20 STEM MRA DEPUY (IRELAND) 2549790

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention