BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE IMPLANT

    MDR report key: 8401240 · Received March 7, 2019

    Report

    Report Number
    1020279-2019-00983
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    February 10, 2019
    Report Date
    June 25, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, NO CLINICAL DOCUMENTATION WAS PRESENTED THEREFORE A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. IT WAS REPORTED THAT A FIRST REVISION HAD BEEN PERFORMED; HOWEVER DETAILS REMAIN UNKNOWN. THE SECOND REVISION INCLUDED AN INCREASED POLY COMPONENT (9MM TO 13 MM) FOR INSTABILITY POST MUA (C-234116 & C-234120) AND PROVIDED APPROPRIATE STABILITY PER REPORT. PT IMPACT WAS THE REVISION PROCEDURE. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE ACTUAL DEVICE INVOLVED OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINTS CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    DR REVISED GEN 2 CR TKR TO A LEGION REVISION FEMUR, CONSTRAINED INSERT ( COMPROMISED LATERAL COLLATERAL) AND KEPT THE ORIGINAL TIBIAL BASEPLATE. WHILE THE PATIENT WAS DOING THEIR PHYSIO ( LEG EXTENSION ) THE FEMUR JUMPED THE POST ON THE POLY. THE SURGEON PERFORMED A MUA AND WAS ABLE TO RELOCATE THE KNEE INTO IT'S PROPER POSITION. HOWEVER, HE WAS NOT HAPPY WITH STABILITY. DR OPENED THE KNEE AND WHEN GOING THROUGH A RANGE OF MOTION HE EXTERNAL ROTATED THE AND THE FEMUR JUMPED THE POST. THE POLY WAS UPSIZED TO A 13MM CONSTRAINED INSERT, AND STABILITY WAS REGAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191715 KNEE IMPLANT PROSTHE, KNEE, PATEFEMOROTIB, SEMI-CONS, CEMEN, POLY/METAL/POLY JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R