BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HOLE ELIM POSITIVE STOP

    MDR report key: 2071526 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06417
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. USING A MALLET TO ENGAGE A HEX TIP SCREWDRIVER WITH THE FEMALE FEATURE OF THE HOLE ELIMINATOR SHOULD NOT BE REQUIRED FOR EXPECTED USE. 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.

    Description of Event or Problem · 1

    DURING A REVISION SURGERY REPORTED SEPARATELY, THE SURGEON USED A SCREWDRIVER TO TRY AND REMOVE THE APEX HOLE ELIMINATOR. HE WAS ABLE TO GET THE SCREW TO ENGAGE, SO HE USED A MALLET TO ENGAGE IT. THE FORCE PUSHED THE ELIMINATOR THROUGH THE CUP AND INTO THE BLADDER AND WAS UNRETRIEVABLE. THIS CAUSED A SURGICAL DELAY OF 10-15 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX HOLE ELIM POSITIVE STOP 87MRA MRA DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention