BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/R NPOR FEM RT SZ 2

    MDR report key: 2831513 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-27722
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. PER THE INITIAL REPORTING BY (B)(4); NO ADDITIONAL INFORMATION IS AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT; HOWEVER, THE INITIAL REPORTING STATED IT WAS NOT SUSPECTED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC*SIGMA C/R NPOR FEM RT SZ 2 FEMORAL KNEE PROSTHESIS JWH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention