BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +5.0

    MDR report key: 8915710 · Received August 21, 2019

    Report

    Report Number
    1818910-2019-101833
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    May 24, 2015
    Report Date
    July 31, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LZO
    UDI-DI
    10603295033660
    PMA / PMN Number
    K071830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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: 7983792. DEVICE HISTORY REVIEW: NO DEVIATIONS OR ANOMALIES WERE NOTED. 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 (B)(4). 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 MEDICAL RECORDS RECEIVED. PPF ALLEGES INFECTION AND ELEVATED METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT UNDERWENT CT AND ARTHROCENTESIS WHICH REVEALED A SIGN OF INFECTION AND DEMONSTRATED SOME LEUKOCYTOSIS. THERE WAS NO OPERATIVE NOTE PROVIDED FOR THE RIGHT HIP SECOND REVISION. THE STEM, CUP AND THE 2 SCREWS WERE ALREADY REPORTED IN THE FIRST REVISION UNDER (B)(4). DOI: (B)(6) 2015. DOR: MAY 24, 2015 (RIGHT HIP) SECOND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707864 DLT TS CER HD 12/14 36MM +5.0 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS, INC. 1818910 7983792 10603295033660

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention