BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS

    MDR report key: 18477569 · Received January 9, 2024

    Report

    Report Number
    0002648920-2024-00009
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    December 16, 2023
    Report Date
    April 2, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    UDI-DI
    00889024633254
    PMA / PMN Number
    K833991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2024-00104, 0009613350-2023-00716. D10: CAT#: 802202802 / ZB 12/14 COCR HD 28MM X +0/ LOT#: 3173761. CAT#: 30.00.49.060 / MS-30 SIZE 6 STD STEM / LOT#: 3151804. G2: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 12 DAYS POST IMPLANTATION DUE TO A DISLOCATION AND LOOSENING OF THE STEM FROM FALLING. ALL COMPONENTS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461825 LINER 28 MM I.D. FOR USE WITH 44/45/46 MM O.D. SHELLS PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. NI 65812788 00889024633254

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention| H SEE H10 NARRATIVE.