BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 6829884 · Received August 30, 2017

    Report

    Report Number
    3002806535-2017-00861
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    August 1, 2017
    Report Date
    March 7, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET (B)(4) LTD FOR EVALUATION AND FORWARDED TO THE QUALITY 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. A VISUAL CHECK OF THE BLISTER AND FOAM INSERT CONFIRMED THAT THERE IS A HAIR PRESENT IN THE PACKAGING. AN ISSUE EVALUATION HAS BEEN RAISED ON THE MANUFACTURING SITE TO INVESTIGATE FURTHER.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THE DEVICE WOULD NOT BE RETURNED FOR MANUFACTURER EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PACKAGING: HAIR FOUND IN INNER STERILE PACKAGING.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED A HAIR WAS FOUND IN THE INNER STERILE PACKAGING. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611207 OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 3964298

    Patients

    Seq Age Sex Outcome Treatment
    1