BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW

    MDR report key: 8598833 · Received May 10, 2019

    Report

    Report Number
    0001825034-2019-02093
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    April 1, 2019
    Report Date
    August 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS- TI LOW PROFILE SCREW, CATALOG #: 103530 LOT #: 2328015, MLRY-HD 3HOLE RLC SHL, CATALOG #: 11-104154 LOT #: 3774190, RINGLOC-X E1, CATALOG #: EP-053654 LOT #: 3650032, DELTA CER FM HD, CATALOG #: 650-0838 LOT #: 2016060741. FOREIGN SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: SCREW 2: 0001825034-2019-02094.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED APPROXIMATELY TWO AND HALF YEARS LATER FOR CUP LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392775 TI LOW PROFILE SCREW PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 2016030066

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R