BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB GVF INS 4 12.5MM

    MDR report key: 3820246 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19107
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 6, 2014
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK033272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVIC E HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PROCEDURE: KNEE POLY EXCHANGE REVISION DUE TO INFECTION. INFECTION IS LOCALIZED TO THE KNEE. PRIMARY PROCEDURE ON (B)(60 2014. PATIENT PRESENTED WITH SWOLLEN KNEE. SURGEON OPENED THE KNEE AND UNDERTOOK A WASH OUT, PUS WAS EVIDENT. LINER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299462 SIGMA STAB GVF INS 4 12.5MM KNEE TIBIAL BEARING/INSERT JWH JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. D12051880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention