BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF CENT HIP 46X28 BRN

    MDR report key: 2901297 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-10572
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK812672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2012 - DOR: (B)(6) 2012 (HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8693 SELF CENT HIP 46X28 BRN HIP PROSTHESIS KWY DEPUY ORTHOPAEDICS, INC. 176837

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Required Intervention