BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HEAD

    MDR report key: 9921006 · Received April 3, 2020

    Report

    Report Number
    0009613350-2020-00164
    Event Type
    Injury
    Date Received
    April 3, 2020
    Date of Event
    December 18, 2019
    Report Date
    August 26, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS NOT NEEDED AS THE ACTUAL COMPLAINED PRODUCT IS (REINFORCEMENT CAGE LEFT 50MM). THEREFORE, THIS REPORT MUST BE DELETED FROM THE SYSTEM. ALL INFORMATION ABOUT THIS CASE IS COVERED IN THE REPORT: 0009613350-2020-00162-1. PLEASE DELETE: 0009613350-2020-00164-1 FROM YOUR SYSTEM.

    Description of Event or Problem · 0

    THIS REPORT IS NOT NEEDED AS THE ACTUAL COMPLAINED PRODUCT IS (REINFORCEMENT CAGE LEFT 50MM). THEREFORE, THIS REPORT MUST BE DELETED FROM THE SYSTEM. ALL INFORMATION ABOUT THIS CASE IS COVERED IN THE REPORT: 0009613350-2020-00162-1.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID RECEIVE X-RAYS, OPERATIVE AND LAB REPORTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN, ABDUCTOR INSUFFICIENCY WITH CORRESPONDING LIMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384714 METASUL HEAD METASUL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R