BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 11X160MM

    MDR report key: 9765438 · Received February 27, 2020

    Report

    Report Number
    0001825034-2020-00922
    Event Type
    Injury
    Date Received
    February 27, 2020
    Date of Event
    June 13, 2017
    Report Date
    February 27, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMINANT MEDICAL DEVICES: RD118852 ¿ M2A CUP ¿ (B)(4); 11-173664 ¿ M2A MOD HEAD ¿ (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING PATIENT EXPERIENCING PAIN AND NOISE. METALLOSIS ALONG WITH OSTEOLYSIS OF THE GREATER TROCHANTER AND SYNOVIAL FLUID WAS FOUND DURING THE SURGERY. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03801, 0001825034 - 2018 - 03800.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO METALLOSIS, OSTEOLYSIS, PAIN, NOISE AND ELEVATED METAL ION LEVELS. DURING THE SURGERY, THE HEAD COMPONENT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228125 MLRY-HD POR FMRL 11X160MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 334210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O