BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP CV TB/IN S3 12.5

    MDR report key: 3172940 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19047
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, LOOSENING OF THE PATELLA AT THE CEMENT/BONE INTERFACE WITH DEPUY CEMENT HAVING BEEN USED AT THE TIME OF ORIGINAL IMPLANTATION, AND POLY WEAR OF THE INSERT (CRACKS AND A WHITE, OXIDIZED AREA). THIRD-BODY WEAR WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274630 PFC SIGMARP CV TB/IN S3 12.5 TIBIAL KNEE INSERT NJL 9616671 DEPUY (IRELAND) 1018235

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention