BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC MOD PLUS TIBIAL TRAY SZ 3

    MDR report key: 2162257 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12302
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) REPORTS: PATIENT RECEIVED REVISION SURGERY OF A TOTAL KNEE REPLACEMENT O.... IMPLANTED WAS THE DEPUY TC3 SYSTEM. ON THE PATIENTS ANNUAL REVIEW IN 2011 THE XRAY SHOWED A FAULT IN THE TIBIAL COMPONENTS (DISPLACEMENT/CRACK BETWEEN TIBIAL AND STEM). THIS WAS ALSO PRESENT IN THE X-RAY TAKEN IN 2010 ON THE PATIENTS ANNUAL REVIEW. SINCE THE PATIENT WAS, AND STILL IS, ASYMPTOMATIC WAS DONE IN 2010 AND AGAIN IN 2011. ON (B)(6), (B)(6) PRESENTED ME WITH THE X-RAY AND ASKED ME TO GET THIS CASE INVESTIGATED. HE IS WONDERING IF DUPUY COULD HAVE A LOOK AT THE X-RAYS, INFORM HIM IF THIS WAS SEEN BEFORE, AND OFFER HIM ANY RELEVANT INFORMATION ON THEIR FINDINGS. SINCE THE IMPLANT ISN'T TAKING OUT WE CAN THEREFORE NOT SUPPLY YOU WITH THIS TO INVESTIGATE. THE DEVISES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. REVIEW OF THE ATTACHED X-RAYS BY (B)(6) PRODUCT DEVELOPMENT CONCLUDED THE TIBIAL STEM BOLT IS FRACTURED. THE TIBIAL TRAY IS SUBSIDING AND REVISION IS REQUIRED. A REVIEW OF THE DHR AND MATERIAL CERTS (FOR THE STEM / STEM BOLT AND TIBIAL TRAY) BY WARSAW MATERIAL SCIENTIST DID NOT REVEAL ANY ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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

    A DISPLACEMENT/CRACK BETWEEN THE TIBIAL TRAY AND STEM WAS IDENTIFIED ON X-RAY. PT HAS NOT YET BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC MOD PLUS TIBIAL TRAY SZ 3 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA 0540123B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA