BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +5

    MDR report key: 2834068 · Received November 15, 2012

    Report

    Report Number
    1818910-2012-26821
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    August 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UF REPORT#(B)(4) SUBMITTED BY HOSPITAL REPORTED THAT A PATIENT WAS REVISED TO ADDRESS INFECTION WITH SEVERE CHRONIC PAIN APPROXIMATELY TWO (2) WEEKS AFTER IMPLANTATION. (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA CER HEAD 12/14 36MM +5 FEMORAL HEAD KWA DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention