BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 5.0MM SCREW

    MDR report key: 2250122 · Received September 15, 2011

    Report

    Report Number
    1818910-2011-18175
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE KNOWN PRODUCT/LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. PRODUCT/LOT INFORMATION WAS NOT PROVIDED FOR THE ASSOCIATED SCREWS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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 LOOSENING OF THE CUP. IT WAS REPORTED THAT A SCREW HAD BACKED OUT AND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY 5.0MM SCREW BONE SCREW HWC DEPUY RAYNHAM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention