BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOLOX DELTA CERAMIC HEAD

    MDR report key: 7767191 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07549
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    October 27, 2009
    Report Date
    August 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MEH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 15-103209, STEM, LOT # UNK; ITEM # UNK, LINER, LOT # UNK; ITEM # 13-104060, CUP, LOT # UNK. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED URINARY PROBLEMS. NO INFORMATION REGARDING TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607684 UNKNOWN BIOLOX DELTA CERAMIC HEAD PROSTHESIS, HIP MEH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other