BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NONFLARED SZ 58MM

    MDR report key: 7453309 · Received April 23, 2018

    Report

    Report Number
    0001825034-2018-02885
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    September 2, 2014
    Report Date
    November 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE OPERATIVE NOTES. OPERATIVE NOTES STATE THAT THE CUP WAS NOTED TO BE IN ABOUT 10-15 DEGREES OF ANTEVERSION AND FEMORAL STEM WAS NOTED TO BE IN ABOUT 7 DEGREES OF ANTEVERSION WHICH MIGHT HAVE LIKELY CONTRIBUTED TO THE INSTABILITY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. HOWEVER, 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). MEDICAL DEVICES: 650-1067, CER OPTION TYPE 1 TPR SLEVE +3 PE 1, 131600; 650-1055, DELTA CERAMIC OPTION HEAD DIA2 8, 986880; EP-200144, ACT ARTIC E1 HIP BRG 28X38MM S44 DIA28, 694930; X180311, BI-METRIC/X POR NC 11X135, 248120 . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02884, 0001825034 - 2018 - 02883, 0001825034 - 2018 - 02942.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT REVISION SURGERY DUE TO RECURRENT INSTABILITY. THE CUP, LINER, AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293644 M2A-38 CUP NONFLARED SZ 58MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 952490

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R