BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE DEVICE

    MDR report key: 7921316 · Received September 30, 2018

    Report

    Report Number
    1020279-2018-01996
    Event Type
    Injury
    Date Received
    September 30, 2018
    Date of Event
    November 15, 2017
    Report Date
    December 5, 2018
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, THE INTRAOPERATIVE FINDINGS OF SIGNIFICANT GOUT CRYSTALS AND APPROXIMATELY 3 LARGE, LOOSE CEMENT PARTICLES WERE MOST LIKELY THE CONTRIBUTING FACTORS TO THE REPORTED PAIN, RESULTANT INSERT PITTING (C-206548) AND THE SYNOVITIS/MAJOR SYNOVECTOMY (C-0213058, C-0213059, C-0213061, C-0213063). THE CONTINUED LIGAMENT LAXITY WAS MOST LIKELY THE CONTRIBUTING FACTOR TO THE REPORTED RETURN OF LEFT KNEE PAIN, INSTABILITY, AND SUBSEQUENT INSERT REVISION/POLY EXCHANGE, AS THE SURGEON WAS REPORTEDLY PLEASED WITH THE OUTCOME OF THE PROCEDURE/INCREASED POLY THICKNESS (C-206548). ALTHOUGH NO ADDITIONAL IMPACT IS ANTICIPATED, THE PATIENT IMPACT BEYOND THE REPORTED SYMPTOMS, LEFT KNEE SYNOVECTOMY, 3RD BODY DEBRIS REMOVAL, INSERT REVISION AND AN EXPECTED POST-OP CONVALESCENCE PERIOD CANNOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYNOVECTOMY WAS PERFORMED DUE TO PAIN. POLY COMPONENT WAS FOUND WITH SIGNS OF PITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762278 UNKNOWN KNEE DEVICE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R