BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 52OD

    MDR report key: 3423074 · Received October 22, 2013

    Report

    Report Number
    1818910-2013-31175
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    September 22, 2012
    Report Date
    October 10, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL IN INVESTIGATION. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT (B)(4) . REASON FOR ORIGINAL COMPLAINT: MANUFACTURING DATE REQUEST- POSSIBLE REVISION NO FURTHER INFO PROVIDED. PLEASE SEE COMMENTS BELOW. NO FURTHER INFORMATION HAS BEEN PROVIDED. NO OUTCOME LETTER NECESSARY AS THE MANUFACTURING DATES HAVE BEEN PROVIDED AS PER THE ORIGINAL REQUEST. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES Z3YEJ1000 AND 1998351. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 1990423 AND 1986718 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Description of Event or Problem · 1

    UPDATE RECEIVED (B)(6) 2013: DOI AND DOR. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540182 ULTAMET MTL INS NEUT 36MM 52OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 1990423

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention