BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -3 PE 1

    MDR report key: 6565118 · Received May 12, 2017

    Report

    Report Number
    0001825034-2017-03212
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Report Date
    September 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03209, 0001825034-2017-03210, 0001825034-2017-03211, 0001825034-2017-03212, AND 0001825034-2017-03213.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS¿ M2A MAGNUM PF CUP P/N US157848 L/N 550400; DELTA CERAMIC OPTION HEAD P/N 650-1055 L/N 381370; TAPERLOC POROUS COATED STEM P/N 51-100060 L/N 3386887; ACTIVE ARTIULCATION E1 HIP BEARING P/N EP-200148 L/N 109250. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 THAT THE PATIENT ALLEGED TO LEFT HIP POPPING AND CLICKING APPROXIMATELY TWO YEARS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346292 CER OPTION TYPE 1 TPR SLEVE -3 PE 1 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 029020

    Patients

    Seq Age Sex Outcome Treatment
    1