BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACETABULAR SHELL

    MDR report key: 7852584 · Received September 6, 2018

    Report

    Report Number
    3002806535-2018-01062
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    August 6, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE LEGAL MANUFACTURER IS ZB WARSAW AND THEREFORE THIS INCIDENT WILL BE REPORTED UNDER WARSAW MEDWATCH FACILITY NUMBER: (B)(4).

    Description of Event or Problem · 0

    REVISION DUE TO IMPLANT FRACTURE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - RLOC-X E1 H/W +3MM 50/36MM 23, ITEM EP-083650, LOT 3911568, THERAPY DATE - (B)(6) 2018. MEDICAL PRODUCT - UNKNOWN CERAMIC HEAD, THERAPY DATE - (B)(6) 2018. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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: 3002806535-2018-01061 AND 3002806535-2018-01063.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A REVISION DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691939 UNKNOWN ACETABULAR SHELL KWA BIOMET UK LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R