BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 28X50 10D LINER

    MDR report key: 2233227 · Received September 2, 2011

    Report

    Report Number
    1818910-2011-17179
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY 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

    PATIENT WAS REVISED TO ADDRESS A SYNTHESE SCREW THAT HAD BEEN PREVIOUSLY IMPLANTED DURING A RECONSTRUCTION OF THE POSTERIOR WALL BACKED OUT AND DAMAGED THE LINER. THE LINER WAS NO LONGER LOCKED INTO THE CUP. ADDITIONAL INFORMATION OBTAINED FROM THE SALES REP INDICATED THAT IT IS POSSIBLE THAT THE CUP WAS NOT POSITIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY 28X50 10D LINER ACETABULAR LINER JDI DEPUY WARSAW ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention