BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB XLK INS 3 8MM

    MDR report key: 2990065 · Received March 5, 2013

    Report

    Report Number
    1818910-2013-13205
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    PK040166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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 INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS ARE AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION 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

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND POLY WEAR. LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/BONE INTERFACE WAS ALSO REPORTED; HOWEVER, THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94332 SIGMA STAB XLK INS 3 8MM TIBIAL KNEE INSERT JWH 9616671 DEPUY (IRELAND) 1804901

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention