BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER 28 MM I.D.

    MDR report key: 17584608 · Received August 21, 2023

    Report

    Report Number
    0002648920-2023-00190
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    July 26, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    UDI-DI
    00889024633360
    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 WAS NOT INVOLVED IN 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: 0001822565-023-02177, 002648920-2023-00196. D10/D11: CONCOMITANT MEDICAL PRODUCTS: CAT #: 802202802 / FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +0 MM NECK LENGTH / LOT #: 3151441. 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 WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATE EIGHT DAYS POST IMPLANTATION DUE TO A DISLOCATION AND FRACTURE TO THE NECK OF THE FEMUR.THE SURGEON NOTED THAT THE STEM HAD EXCESSIVE ANTEVERSION, THE BIPOLAR SHELL WAS TOO BIG. THE HEAD, LINER AND STEM WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491576 LINER 28 MM I.D. PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. NI 65745198 00889024633360

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Hospitalization| R SEE H10 NARRATIVE