BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMED OXFORD TIBIA 2 RK

    MDR report key: 8160880 · Received December 13, 2018

    Report

    Report Number
    3002806535-2018-01272
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 27, 2018
    Report Date
    February 8, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON INVESTIGATION IT HAS BEEN DETERMINED THAT THE REPORTED EVENT WAS RELATED TO STERILISATION OF THE PRODUCTS AND NOT RELATED TO ANY MANUFACTURING OR DESIGN DEFECT OR MALFUNCTION OF THE REPORTED INSTRUMENT SET. ZIMMER BIOMET WAS NOT RESPONSIBLE FOR STERILISATION AND PACKAGING OF THE INSTRUMENT SET IN QUESTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN OPENING THE STERILE SIEVES, HEAVY MOISTURE/HUMIDITY WAS SEEN ON THE BIOMED OXFORD TIBIA 2 RK OF RK-B201-012- ON. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND HAD TO BE DISCHARGED DUE TO THE WET SIEVE. THE OP WAS MOVED. A PATIENT RISK WITH RESPECT TO THE WET SIEVE CANNOT BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN OPENING THE STERILE SIEVES, HEAVY MOISTURE/HUMIDITY WAS SEEN ON THE BIOMED OXFORD TIBIA 2 RK OF RK-B201-012-ON. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND HAD TO BE DISCHARGED DUE TO THE WET SIEVE. THE OP WAS MOVED. A PATIENT RISK WITH RESPECT TO THE WET SIEVE CANNOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998896 BIOMED OXFORD TIBIA 2 RK UNKNOWN HRY BIOMET UK LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1