BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSERT SZ5 8MM

    MDR report key: 4243297 · Received November 11, 2014

    Report

    Report Number
    1818910-2014-31560
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2003
    Report Date
    November 26, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655
    Product Code
    JWH
    PMA / PMN Number
    PK943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S MEDICAL RECORDS WERE RECEIVED. THE MEDICAL RECORDS INDICATE UPON REVISION THE PATIENT WAS FOUND TO HAVE MINIMAL WEAR ON THEIR PATELLAR COMPONENT. THE PATIENT'S PATELLAR COMPONENT IS BEING REPORTED AT THIS TIME. ALL AVAILABLE X-RAYS WERE REVIEWED, AND NO EVIDENCE OF ANYTHING INDICATIVE OF A DEVICE NONCONFORMANCE WAS FOUND. THE ADDITIONAL INFORMATION RECEIVED DOES NOT CHANGE THE OUTCOME OF THE INITIAL INVESTIGATION. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE REC¿D 11/26/2014 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS WERE REVIEWED FOR MDR REPORTABILITY. THE MEDICAL RECORDS INDICATE UPON REVISION THE PATIENT WAS FOUND TO MY MINIMAL WEAR ON THEIR PATELLAR COMPONENT. THE PATIENT'S PATELLAR COMPONENT IS BEING REPORTED AT THIS TIME. THE COMPLAINT WAS UPDATED ON: 12/04/2014.

    Description of Event or Problem · 1

    CLINICAL STATES POLY WEAR SYNOVITIS WITH SOME INSTABILITY.UPDATE RECEIVED 10/20/2014. THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN SECONDARY TO ACUTE SYNOVITIS. COMPLAINT WAS UPDATED ON 11/5/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725902 PFC SIGMA CRVD INSERT SZ5 8MM KNEE TIBIAL BEARING/INSERT JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655 54379A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention