BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +8.5

    MDR report key: 4810978 · Received June 2, 2015

    Report

    Report Number
    1818910-2015-22430
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4). 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

    ADDITIONAL NARRATIVE: PATIENT WAS REVISED DUE TO PSEUDOTUMOR AND PAIN. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE INSERT. A REVIEW OF MANUFACTURING RECORDS OF LOT 2171775 IDENTIFIED NO ANOMALIES. (B)(4) PRODUCTS WERE MANUFACTURED AND PLACED INTO STOCK ON 09 JUN 2006. NO OTHER REPORTS WERE IDENTIFIED AGAINST THE FEMORAL HEAD. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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 DUE TO PSEUDOTUMOR AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354764 DELTA CER HEAD 12/14 36MM +8.5 HIP FEMORAL HEAD LZO DEPUY (IRELAND) 9616671 1135016

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention