BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM ST,36+8L NK,18X13X160

    MDR report key: 8281044 · Received January 28, 2019

    Report

    Report Number
    1818910-2019-82441
    Event Type
    Injury
    Date Received
    January 28, 2019
    Report Date
    January 7, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    UDI-DI
    10603295171034
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 : 1914426. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION. THERE WERE 1 NC AND 1 CAPA ASSOCIATED. DEVINT ¿ 1020: AS THESE ARE EXTRA CHECKS IN THE PROCESS AND DEVINT-1020 HAS NO CORRELATION IN THE COMPLAINT DESCRIPTION. CAPA-179 HAS NO CORRELATION IN THE COMPLAINT. 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. 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

    (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

    PINNACLE PPF AND STICKER SHEETS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76166 SROM*STM ST,36+8L NK,18X13X160 S-ROM HIP SYSTEM : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS, INC. 1818910 1914426 10603295171034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention