BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR INTRODUCER

    MDR report key: 12873493 · Received November 25, 2021

    Report

    Report Number
    3002806535-2021-00510
    Event Type
    Malfunction
    Date Received
    November 25, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWZ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO MAKE A CORRECTION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, H1, H2, H10. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR REPORT SHOULD NOT HAVE BEEN SUBMITTED UNDER THE CURRENT MANUFACTURER. THIS EVENT WILL BE REPORTED BY MEDWATCH FACILITY WARSAW BIOMET - (B)(4). THEREFORE, BIOMET UK LTD. WILL NOT BE SENDING ANY FOLLOW-UPS REGARDING THIS PRODUCT.

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE LOCATION UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ACETABULAR INTRODUCER WAS MISSING FROM THE KIT. A REPLACEMENT ITEM HAD TO BE SOUGHT FROM ANOTHER HOSPITAL. SURGERY START TIME WAS DELAYED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ACETABULAR INTRODUCER WAS MISSING FROM THE LOANER KIT. A REPLACEMENT ITEM HAD TO BE SOUGHT FROM ANOTHER HOSPITAL. SURGERY START TIME WAS DELAYED SLIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773957 ACETABULAR INTRODUCER HIP ARTHROPLASTY KWZ BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown