BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 28MM +1.5

    MDR report key: 4192539 · Received October 22, 2014

    Report

    Report Number
    1818910-2014-30417
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    KWA
    PMA / PMN Number
    PK073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED INTO THE LEEDS QUALITY DEPARTMENT ON 10 OCTOBER 2014 WITH THE FOLLOWING COMMENT: PATIENT OF (B)(4) RECEIVED DELTA TS CERAMIC HEAD IN ABOUT 2013. REVISION OF HEAD AND INLAY BECAUSE OF BREAKAGE OF CERAMIC TS HEAD IN (B)(6) 2014. A COMPLAINTS DATABASE SEARCH AND REVIEW OF MANUFACTURING RECORDS IDENTIFIED NO ANOMALIES. A REVIEW OF THE RETURNED X-RAYS AND MEDICAL RECORDS DID NOT PROVIDE ANY INFORMATION AS TO THE CAUSE OF THE FAILURE. WITHOUT FURTHER INFORMATION OR RETURN OF PRODUCTS THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND MONITORED THOUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. NO FURTHER ACTIONS ARE IDENTIFIED. POST MARKET SURVEILLANCE IS PER SEP 419.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE CATALOG NUMBER AND LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    THIS IS A DUPLICATE OF MW 1818910-2015-19624 THEREFORE THIS REPORT IS BEING REJECTED.

    Description of Event or Problem · 1

    PATIENT OF (B)(4) RECEIVED DELTA TS CERAMIC HEAD IN ABOUT 2013. REVISION OF HEAD AND INLAY BECAUSE OF BREAKAGE OF CERAMIC TS HEAD IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671673 DLT TS CER HD 12/14 28MM +1.5 HIP FEMORAL HEAD KWA DEPUY (IRELAND) 9616671 3594085

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention