BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 58 OR 70ODX32ID

    MDR report key: 3001600 · Received March 13, 2013

    Report

    Report Number
    1818910-2013-13715
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDL
    PMA / PMN Number
    PK900832
    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THIS PRODUCT/LOT COMBINATION WAS RELEASED FOR DISTRIBUTION IN JANUARY 1992. IT IS REASONABLE TO CONCLUDE THIS LINER HAD BEEN IMPLANTED FOR AN EXTENDED PERIOD OF TIME. THIS PRODUCT CODE IS ALSO NOW OBSOLETE. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105672 HYLAMER 10D 58 OR 70ODX32ID ACETABULAR LINER JDL DEPUY ORTHOPAEDICS, INC. 1818910 851370

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention