BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLAMER 10D 56 OR 68ODX32ID

    MDR report key: 3172496 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19013
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JDI
    PMA / PMN Number
    PK900832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH A COMPETITOR MANUFACTURED FEMORAL PRODUCTS. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. IN ADDITION THIS PRODUCT CODE IS 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.

    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

    (B)(4), DEPUY ORTHOPAEDICS IS PROVIDING THE FOLLOWING INFORMATION, AS DEPUY ORTHOPAEDICS DID NOT MANUFACTURE, OR IMPORT, THE FOLLOWING DEVICE(S): MANUFACTURER: ZIMMER FEMORAL HIP STEM EVENT: THIS WAS USED IN CONJUNCTION WITH DEPUY PRODUCT IN THIS PATIENT.

    Description of Event or Problem · 1

    DURING A REVISION TO ADDRESS LOOSENING OF A COMPETITOR STEM, SLIGHT POLY WEAR OF THE DEPUY LINER WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273294 HYLAMER 10D 56 OR 68ODX32ID ACETABULAR LINER JDI 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 889230

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention