BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM TIBIAL TRAY SZ4

    MDR report key: 3173019 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-18993
    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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. TWO X-RAY IMAGES WERE PROVIDED: ONE WEIGHTBEARING A/P VIEW AND ONE M/L VIEW, BOTH DATED (B)(6) 2013. REDUCED RADIOGRAPHIC DENSITY IS APPARENT UNDER MEDIAL SIDE OF TIBIAL PLATEAU AND MAY INDICATE BONE LOSS. CANNOT CONFIRM TIBIAL SUBSIDENCE WITH THE INFORMATION PROVIDED. THE PATIENT IS A REPORTED FEMALE WITH A CALCULATED BMI OF (B)(6). THE PATIENT IS CONSIDERED OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TEND TO ADVERSELY AFFECT KNEE REPLACEMENT IMPLANTS. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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

    REASON FOR REVISION: THE TIBIA HAD SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273099 MBT CEM TIBIAL TRAY SZ4 TIBIAL TRAY NJL 9616671 DEPUY IRELAND 1049744

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention