BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL POLYETHYLENE LINER

    MDR report key: 6836313 · Received August 31, 2017

    Report

    Report Number
    0001825034-2017-06847
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    September 30, 2013
    Report Date
    August 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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. CONCOMITANT PRODUCT(S): A 650-1058, CER BIOLOXD OPTION HD 40MM, 086940. A 13-104054, M/H RADIAL SOLID/APX SHL 54MM, 207630. A 650-1065, CER OPTION TYPE 1 TPR SLEVE -3, 903480. A 13-103206, TAPERLOC POR RED/LAT 12.5X145, 771820. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-04060, 0001825034-2017-06934.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP REVISION DUE TO PAIN. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615463 ARCOMXL POLYETHYLENE LINER PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 185770

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R