BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY STD/LRG 12.5 MM LCS INSERT

    MDR report key: 2493938 · Received March 16, 2012

    Report

    Report Number
    1818910-2012-06357
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 20, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFORMATION. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    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

    PATIENT WAS REVISED TO ADDRESS SPIN OUT. THE POLY WAS WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY STD/LRG 12.5 MM LCS INSERT KNEE JWH DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention