BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC KEEL TIB TRAY CEM SZ4

    MDR report key: 3212289 · Received July 9, 2013

    Report

    Report Number
    1818910-2013-20715
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE DID NOT CONFIRM THE REPORTED SUBSIDENCE AND MAL-POSITIONING; HOWEVER, EVIDENCE WAS FOUND SUGGESTING DEVICE LOOSENING WHILE IN VIVO. 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 WI-7915 APPENDIX A; REV. D. NO INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING OR ITS POSSIBLE CONTRIBUTION TO THE REPORTED SUBSIDENCE AND MAL-POSITIONING. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE OR IDENTIFY PRODUCT ERROR AS A CONTRIBUTING FACTOR, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND MALPOSITIONING OF THE TIBIAL TRAY. IT WAS NOTED THAT THE PATIENT HAD DEVELOPED A CYST UNDER THE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311893 PFC KEEL TIB TRAY CEM SZ4 TIBIAL KNEE PROSTHESIS JWH 9616671 DEPUY (IRELAND) 1198859

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention