BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS COCR SIZE D LM STD

    MDR report key: 7154026 · Received December 29, 2017

    Report

    Report Number
    3002806535-2017-01249
    Event Type
    Injury
    Date Received
    December 29, 2017
    Date of Event
    December 12, 2017
    Report Date
    March 28, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - OXF ANAT BRG LT LG SIZE 3 PMA, ITEM 159554, LOT 222430. CONCOMITANT MEDICAL PRODUCT - OXF TWIN-PEG CMNTD FEM LG PMA ITEM 161470, LOT 0282620. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A INITIAL LEFT TOTAL KNEE PROCEDURE AND SUBSEQUENTLY THE REVISION PROCEDURE WAS PERFORMED DUE TO LOOSENING OF TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934591 OXFORD PKS COCR SIZE D LM STD KNEE PROTHESIS NRA BIOMET UK LTD. 101620

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R