BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR ACET CUP 50MM

    MDR report key: 2943933 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-11910
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 14, 2011
    Report Date
    January 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, 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

    (B)(4) REPORT ((B)(4)) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT WAS REVISED TO ADDRESS PAIN AND ASEPTIC LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESION REACTION AND A LOOSE ACETABULAR COMPONENT. EXTENSIVE METALLIC DEBRIS WITH BLACKENING OF THE ENTIRE HIP CAPSULE AND PSEUDOCAPSULE WAS FOUND, AS WELL AS IN THE BONE ITSELF..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49383 PINNACLE SECTOR ACET CUP 50MM ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1