BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LINER

    MDR report key: 9711868 · Received February 14, 2020

    Report

    Report Number
    0001825034-2020-00400
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Report Date
    January 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN-UNKNOWN CUP-UNKNOWN, UNKNOWN-UNKNOWN STEM-UNKNOWN, UNKNOWN-UNKNOWN HEAD-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03307-1, 0001825034-2019-03308-1. 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 THE PATIENT UNDERWENT A LEFT HIP REVISION 7-YEAR POST OPERATION DUE TO JOINT POPPING IN AND OUT OF SOCKET AND CUP MALPOSITION. DURING THE PROCEDURE, THE SOCKET (E-POLY LINER) FRACTURED AND THERE WAS BLACK DEBRIS FROM THE BALL (HEAD) SCRAPING ON THE SHELL. 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
    178198 UNKNOWN LINER PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R