BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP CV TB/IN S3 12.5

    MDR report key: 2930023 · Received January 25, 2013

    Report

    Report Number
    1818910-2013-11538
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4). PATIENT MEDICAL RECORDS AND X-RAYS WERE PROVIDED. REVIEW OF THE SUPPLIED INPUTS CONFIRMED THE REPORTED CYST. THE PATHOGENESIS OF CYST FORMATION IS UNCLEAR AND CONSIDERED TO BE DUE TO A COMBINATION OF BIOLOGIC AND MECHANICAL FACTORS. IT CANNOT BE DETERMINED THAT THE COMPLAINT IS PRODUCT RELATED. REVIEW OF THE SUPPLIED INPUTS DID NOT CONFIRM THE REPORTED DEVICE LOOSENING. BASED ON THE INABILITY TO DETERMINE A 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

    PATIENT WAS REVISED TO ADDRESS ANTERIOR KNEE PAIN AND A CYSTIC FORMATION IN THE SUPERIOR ASPECT OF HER PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35278 PFC SIGMARP CV TB/IN S3 12.5 TIBIAL KNEE INSERT NJL DEPUY (IRELAND) 3071727

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention