BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML/TL ENDR REP LINER 28X44LP

    MDR report key: 4143342 · Received October 6, 2014

    Report

    Report Number
    1818910-2014-29432
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK944538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WAS REVISED TO ADDRESS INSTABILITY. IT WAS REPORTED THAT A LINER HAD BEEN CEMENTED INTO THE ACETABULAR CUP. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE KNOWN PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A DHR REVIEW OR LOT SPECIFIC DATABASE SEARCH WAS NOT POSSIBLE FOR THE ADDITIONAL PRODUCT ASSOCIATED WITH THIS REPORT AS LOT CODE(S) WAS NOT PROVIDED. IT IS NOT RECOMMENDED TO CEMENT A LINER WITHIN AN ACETABULAR CUP. IT IS NOT POSSIBLE TO DERTEMINE IF THE OFF LABEL USE IS THE CAUSE OF THE INSTABILITY. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE 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.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623046 AML/TL ENDR REP LINER 28X44LP HIP ACETABULAR INSERT/LINER HRY 1818910 DEPUY ORTHOPAEDICS, INC. V68PP1005

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention