BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON NEUT 52OD X 28ID

    MDR report key: 3111024 · Received May 14, 2013

    Report

    Report Number
    1818910-2013-17021
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    HRY
    PMA / PMN Number
    PK944538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINAL IMPLANT DATE: 2001 (EXACT DATE UNKNOWN). REVISION DATE: (B)(6) 2013 (DR (B)(6) HOSPITAL). REVISION OF LINER AND EXETER HEAD. IMPLANTS REMOVED FROM PATIENT: DURALOC LOCKING RING SIZE 52 AND DURALOC LINER 52/28, LOT XKB30. CUP STABLE AND LEFT INSITU. REVISION FOR OSTEOLYSIS. X-RAYS AVAILABLE. PATIENT INITIALS, GENDER AND DOB ARE PROVIDED. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS VALID PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. IT WAS INITIALLY REPORTED THAT THE DEPUY ACETABULAR LINER WAS USED IN CONJUNCTION WITH A COMPETITOR FEMORAL HEAD. THIS USE OF DEPUY DEVICES IS NOT RECOMMENDED AND IS CONSIDERED OFF LABEL USE. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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

    REVISION FOR OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212548 ENDURON NEUT 52OD X 28ID ACETABULAR LINER HRY DEPUY ORTHOPAEDICS XKB30

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention