BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL ARCOMXL LNR 36MM E

    MDR report key: 12751398 · Received November 4, 2021

    Report

    Report Number
    0001825034-2021-03045
    Event Type
    Injury
    Date Received
    November 4, 2021
    Report Date
    November 3, 2021
    Product Code
    LPH
    UDI-DI
    00880304524972
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: CAT#010000663 G7 PPS LTD ACET SHELL 52E LOT#6142979; CAT#51-104100 TPRLC 133 T1 PPS HO 10X140MM LOT#3195404; UNK BIOLOX HEAD. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 PATIENT IS EXPERIENCING PAIN, DIFFICULTY WALKING AND DIFFICULTY SLEEPING 3 YEARS POST IMPLANTATION. PATIENT STATED SHE THINKS SHE MAY BE ALLERGIC TO THE TITANIUM AND IS HAVING TESTING DONE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653582 G7 NEUTRAL ARCOMXL LNR 36MM E PROSTHESIS, HIP LPH N/A 6159313 00880304524972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other