BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACS HIP LINER

    MDR report key: 3973013 · Received August 1, 2014

    Report

    Report Number
    1818910-2014-24775
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. COMPLAINT TO PART 803-22, DEPUY ORTHOPAEDICS IS PROVIDING THE FOLLOWING INFORMATION, AS DEPUY ORTHOPAEDICS DID NOT MANUFACTURE, OR IMPORT, THE FOLLOWING DEVICE(S): MANUFACTURER: ¿NON DEPUY PRODUCT¿ EVENT: THIS WAS USED IN CONJUNCTION WITH DEPUY PRODUCT IN THIS PATIENT. 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS 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 NOT PROVIDED. PER THE INITIAL REPORTING; THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITHOUT DEVICE EXAMINATION. HOWEVER ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. 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

    THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS, POLY WEAR OF THE LINER, AND LOOSENING OF A COMPETITOR STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450160 UNKNOWN DEPUY ACS HIP LINER HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention