BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMK CONGR PS INS SIZE 4 14MM

    MDR report key: 2211804 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14750
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K954684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE BY LOT CODE WAS 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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

    PT WAS REVISED TO ADDRESS POLY WEAR AND COLLAPSE OF THE INSERT, WITH PAIN.

    Description of Event or Problem · 1

    CUSTOMER COMMENTS: PATIENT WAS REVISED TO ADDRESS COLLAPSE OF THE TIBIA WITH PAIN. POLY WEAR WAS NOTED ON THE TIBIAL INSERT. DOI APPROX 1994 - DOR (B)(6) 2011 (RIGHT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMK CONGR PS INS SIZE 4 14MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention