BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER INSERT 36IDX52OD

    MDR report key: 3181294 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19475
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 25, 2013
    Manufacturer
    9616671 DEPUY IRELAND
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT SOLD IN THE US.

    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. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013 PRODUCT DETAILS RECEIVED.

    Description of Event or Problem · 1

    REASON FOR REVISION: PATIENT HAS AN INFECTION OF THEIR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282495 DELTA CER INSERT 36IDX52OD ACETABULAR CERAMIC LINER KWA 9616671 DEPUY IRELAND 5205006

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention