BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOID COMPONENT

    MDR report key: 2597681 · Received June 4, 2012

    Report

    Report Number
    1818910-2012-14217
    Event Type
    Injury
    Date Received
    June 4, 2012
    Date of Event
    May 25, 2012
    Report Date
    May 25, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    HSD
    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS UNAVAILABLE. PROVIDED INFORMATION STATES THE GLENOID COMPONENT WAS REMOVED AND THE GLENOID SOCKET DEFECTS WERE BONE GRAFTED. THE PATIENT WAS CONVERTED FROM A TOTAL SHOULDER TO A HEMI ARTHROPLASTY. THE GLENOID COMPONENT WAS IMPLANTED FOR 18 YEARS. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND LOOSENING OF THE GLENOID COMPONENT AT THE CEMENT/IMPLANT INTERFACE. THE GLENOID MIGRATED INFERIORLY. THE MANUFACTURER OF THE CEMENT USED IN THE PRIMARY SURGERY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN GLENOID COMPONENT GLENOID PROSTHESIS HSD DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention