BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC CONST LINER 54X32

    MDR report key: 3875235 · Received June 16, 2014

    Report

    Report Number
    1818910-2014-20984
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    KWY
    PMA / PMN Number
    PP960054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE KNOWN PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A DHR REVIEW OR LOT SPECIFIC DATABASE SEARCH WAS NOT POSSIBLE FOR THE ADDITIONAL PRODUCT ASSOCIATED WITH THIS REPORT AS LOT CODE(S) WAS NOT PROVIDED. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352546 DURALOC CONST LINER 54X32 HIP ACETABULAR INSERT/LINER KWY DEPUY ORTHOPAEDICS, INC.-1818910 CJ5AV1000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention