BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIAMETER COBALT CHROMIUM MODULAR HEAD -6MM NECK

    MDR report key: 7546166 · Received May 25, 2018

    Report

    Report Number
    0001825034-2018-03565
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    April 23, 2018
    Report Date
    September 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO PRODUCT BEING DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: BIOMET EXC ABT CMTD ARC ML CUP 28X50, ITEM#: AR-122850, LOT#: 2705098. BIOMET MLRY-HD POR FMRL 11 X 160 MM, ITEM#: 11-104111, LOT#: 070970.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. UDI: (B)(4). REPORT SOURCE, FOREIGN - (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION OF HEAD APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO BURSITIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388744 28MM DIAMETER COBALT CHROMIUM MODULAR HEAD -6MM NECK HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A J3030610

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R