BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BEARING POLYETHYLENE

    MDR report key: 3033386 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-14839
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    September 19, 2012
    Report Date
    March 4, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, PROVIDED MEDICAL RECORDS SUGGEST PATIENT TRAUMA FOUR DAYS POST-PRIMARY SURGERY WAS A POSSIBLE CONTRIBUTING FACTOR. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE OR PRODUCT ERROR AS A CONTRIBUTING FACTOR, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS 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

    PATIENT CONTACTED DEPUY STATING THEY ARE EXPERIENCING KNEE PAIN AND BUCKLING. MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED DUE TO PAIN AND A RUPTURED MEDICAL CRUCIATE LIGAMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136120 UNKNOWN DEPUY BEARING POLYETHYLENE INSERT JDI 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention