BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF TRL BRG W/SLOTS MED 3MM MM

    MDR report key: 7789576 · Received August 16, 2018

    Report

    Report Number
    3002806535-2018-01011
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 18, 2018
    Report Date
    March 7, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO A RESEARCH ENGINEER FOR INVESTIGATION. THE DHR FOR THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. THE FRACTURE OF THE OXFORD TIBIAL TRIAL HAS EVIDENCE OF ABNORMAL STRESSES POTENTIALLY THE USE OF A UP AND DOWN ROCKING MOTION EXERTED DURING INSERTION OR REMOVAL OF THE BEARING USING THE OXFORD TRIAL TIBIAL BEARING INSERTER/EXTRACTOR. DESIGN, MATERIAL AND MECHANICAL PROPERTIES ENSURE THAT THE INSTRUMENTS ACHIEVE THEIR INTENDED PERFORMANCE. LIFETIME MAY VARY AMONG DIFFERENT INSTRUMENT TYPES AND DEPENDS ON THE USAGE, I.E. NUMBER OF APPLICATIONS AND STERILIZATION CYCLES AS WELL AS INDIVIDUAL HANDLING BY THE CUSTOMER. END OF LIFE IS NORMALLY DETERMINED BY WEAR AND DAMAGE INFLICTED DURING USE. THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    PRODUCT CRACKED WHILE DOING TRIAL.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PRODUCT CRACKED WHILE DOING TRIAL.

    Description of Event or Problem · 1

    PRODUCT CRACKED WHILE DOING TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633120 OXF TRL BRG W/SLOTS MED 3MM MM HRY BIOMET UK LTD. ZB150401

    Patients

    Seq Age Sex Outcome Treatment
    1