BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 8617214 · Received May 16, 2019

    Report

    Report Number
    0001822565-2019-02047
    Event Type
    Injury
    Date Received
    May 16, 2019
    Report Date
    July 2, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT 0001822565-2019-02047-1 WAS CREATED UNDER THE INCORRECT MFR#. THIS DEVICE IS CORRECTLY SUBMITTED IN 0002648920-2019-00491. MLB 29-JUN-2019.

    Description of Event or Problem · 0

    THIS REPORT 0001822565 -2019 -02047-1 WAS CREATED UNDER THE INCORRECT MFR#. THIS DEVICE IS CORRECTLY SUBMITTED IN 0002648920-2019-00491.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN UNKNOWN LINER LOT# UNKNOWN, ITEM# UNKNOWN UNKNOWN STEM LOT# UNKNOWN, ITEM# UNKNOWN UNKNOWN HEAD LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 02046, 0001822565 - 2019 - 02045, 0001822565 - 2019 - 02041.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS BEING CONSIDERED FOR A REVISION APPROXIMATELY 10 YEARS POST INITIAL IMPLANTATION FOR UNKNOWN REASON. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408953 UNKNOWN CUP PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other