BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 52OD X 32ID

    MDR report key: 3111594 · Received May 14, 2013

    Report

    Report Number
    1818910-2013-17057
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK944538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IT IS KNOWN THAT THIS PRODUCT/LOT COMBINATION WAS RELEASED FOR DISTRIBUTION IN JULY 1996 AND THIS PRODUCT CODE HAS BEEN OBSOLETE SINCE SEPTEMBER 2002. ALTHOUGH THE DATE OF INSERTION WAS NOT PROVIDED, IT IS REASONABLE TO CONCLUDE THE LINER HAD BEEN IMPLANTED FOR AN EXTENDED PERIOD OF TIME. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS 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.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212319 HYLAMER 10D 52OD X 32ID HIP LINER HRY 1818910 DEPUY ORTHOPAEDICS, INC. 797790

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention