BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +8.5

    MDR report key: 8549201 · Received April 25, 2019

    Report

    Report Number
    1818910-2019-91568
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    April 20, 2015
    Report Date
    April 4, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LZO
    UDI-DI
    10603295033677
    PMA / PMN Number
    K071830
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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 ==> 7840025. DEVICE HISTORY REVIEW ==> (B)(4) WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE NO NCS OR DEVIATIONS ASSOCIATED WITH THIS LOT. 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.

    Description of Event or Problem · 1

    PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2014 - DOR: (B)(6) 2015 (RIGHT HIP); PLEASE SEE (B)(4) FOR THE RIGHT HIP 1ST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346371 DLT TS CER HD 12/14 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS, INC. 1818910 7840025 10603295033677

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention