BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNICOMPARTMENTAL KNEE CEMENTLESS RIGHT MEDIAL TIBIAL TRAY SIZE AA

    MDR report key: 6049071 · Received October 21, 2016

    Report

    Report Number
    3002806535-2016-00797
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. RETURNED PACKAGING SHOWED SCRATCHES AND WEAR. IT WAS DETERMINED THE DAMAGE RESULTED FROM MULTIPLE HANDLING AND TRANSPORTATION WHERE THE CARDBOARD CARRIER CONTAINING THE BLISTER PACK HAS MOST LIKELY HAD A HEAVY IMPACT AND CAUSED THE IMPLANT INSIDE THE BLISTER TO AGITATE AGAINST THE POUCH OVER TIME AND AFTER EXCESSIVE AGITATION, CAUSE THE POUCH TO SPLIT, THUS COMPROMISING THE POUCH STERILE BARRIER.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE STERILE PACKAGING WAS NOTED TO BE TORN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AFTER A DELAY OF 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700192 OXFORD UNICOMPARTMENTAL KNEE CEMENTLESS RIGHT MEDIAL TIBIAL TRAY SIZE AA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 1398350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention