BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR LINER

    MDR report key: 3072367 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15709
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT WAS REVISED ON (B)(6) 2012 TO ADDRESS LINER FRACTURE AND DISASSOCIATION FROM THE CUP, AND AGAIN ON (B)(6) 2013 FOR THE SAME REASON, WHICH THE SURGEON SAID MAY HAVE OCCURRED DUE TO THE CUP BEING TOO VERTICAL. POLY WEAR WAS ALSO REPORTED. DOI (B)(6) 2008 - DOR (B)(6) 2012 (LINER & HEAD) & (B)(6) 2013 (CUP, LINER, HEAD) (LEFT HIP) UPDATE: (B)(6) 2013 - PATIENT'S PRIMARY AND REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION LIGHT BLACK FLUID WAS FOUND IN THE JOINT ALONG WITH BURNISHING INSIDE THE CUP. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE DEVICES 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 CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. OPERATIVE NOTES AND ONE POOR QUALITY X-RAY IMAGE WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY 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 ON (B)(6) 2012 TO ADDRESS LINER FRACTURE AND DISASSOCIATION FROM THE CUP, AND AGAIN ON (B)(6) 2013 FOR THE SAME REASON, WHICH THE SURGEON SAID MAY HAVE OCCURRED DUE TO THE CUP BEING TOO VERTICAL. POLY WEAR WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175288 UNKNOWN DEPUY ACETABULAR LINER ACETABULAR LINER KWA 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention