BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 64MM

    MDR report key: 2924487 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11261
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    October 12, 2011
    Report Date
    January 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    MAUDE REPORT (B)(4) VOLUNTARILY SUBMITTED BY PATIENT STATES THAT THEY WERE REVISED TO ADDRESS GROIN PAIN, DISCOMFORT, AND NUMBNESS. DOI (B)(6) 2010 - DOR (B)(6) 2011 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE LINER AND HEAD AS THE PRODUCT AND 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.

    Description of Event or Problem · 1

    MAUDE REPORT ((B)(4)) VOLUNTARILY SUBMITTED BY PATIENT STATES THAT THEY WERE REVISED TO ADDRESS GROIN PAIN, DISCOMFORT, AND NUMBNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31253 PINNACLE SECTOR II CUP 64MM ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. BX5F21000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention