BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEM HD 40MM TYPE 1 +6MM

    MDR report key: 10739834 · Received October 27, 2020

    Report

    Report Number
    0001825034-2020-03869
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    March 16, 2020
    Report Date
    February 1, 2021
    Manufacturer
    .
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM#11-301312, ARCOS CON SZ B HI 60MM, LOT #935070; ITEM#11-300818, ARCOS 18X150MM SPL TPR DIST, LOT #576520; ITEM#16-104170, RNGLC+ LTD HOLE FIN SHELL SZ70, LOT #124780R; THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03870.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY 6 MONTHS LATER DUE TO UNKNOWN REASONS. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204829 COCR FEM HD 40MM TYPE 1 +6MM PROSTHESIS, HIP PBI . N/A 6372225

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R SEE H10 NARRATIVE