BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NM1014-77CERMC TH BALL32 +0 SH

    MDR report key: 3133750 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-17775
    Event Type
    Injury
    Date Received
    May 29, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    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. PER THE INITIAL REPORTING BY THE DEPUY CLINICAL TEAM, NO ADDITIONAL INFORMATION IS AVAILABLE. IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. THE INVESTIGATION HAS ALSO DETERMINED THAT BOTH PROVIDED PRODUCT CODES ARE OBSOLETE. BASED ON THE INVESTIGATION, 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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES A LINER AND HEAD EXCHANGE FOR RECURRENT DISLOCATION, POLYETHYLENE WEAR AND PAIN 20.5 YEARS AFTER PRIMARY THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235383 NM1014-77CERMC TH BALL32 +0 SH HEAD JDI 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention