BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 8755105 · Received July 2, 2019

    Report

    Report Number
    0002648920-2019-00490
    Event Type
    Injury
    Date Received
    July 2, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K840643
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO MEDICAL RECORDS REGARDING THE REVISION WERE RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #00771101300 FEMORAL STEM LOT #60968916, ITEM #00631005632 LINER LOT #61300290, ITEM #00620005622 SHELL LOT #61316056. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCTS REMAIN IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 -2019 -00491, 0001822565 -2019 -02044-1, 0001822565 -2019 -02045-1.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. APPROXIMATELY, TEN YEARS POST OP THE PATIENT IS BEING CONSIDERED FOR REVISION DUE TO PATIENT ALLEGATIONS OF INJURIES. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546743 FEMORAL HEAD HIP PROSTHESIS JDI ZIMMER MANUFACTURING B.V. N/A 61338132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other