BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +5.0

    MDR report key: 9192123 · Received October 15, 2019

    Report

    Report Number
    1818910-2019-109954
    Event Type
    Injury
    Date Received
    October 15, 2019
    Report Date
    September 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT ==> 7873344. DEVICE HISTORY REVIEW ==> (B)(4) WERE MANUFACTURED AS PER SPECIFICATION AND ALL MATERIALS MET SPECIFICATION. NO RELATED DEVIATIONS OR ANOMALIES IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES ELEVATED METAL IONS. LINER IS POLYETHYLENE. STEM WAS ALREADY REPORTED IN THE FIRST REVISION. DOI: (B)(6) 2014. DOR: NONE REPORTED, (RIGHT HIP). THIS PC IS FOR THE ALLEGATIONS AFTER FIRST REVISION. PLEASE SEE (B)(4) FOR THE FIRST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985391 DLT TS CER HD 12/14 36MM +5.0 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 1365-36-720 7873344 10603295033660

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention