BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA FEM POST AUG SZ4 4MM

    MDR report key: 3021896 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-14497
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    CONCLUSION AND JUSTIFICATION STATUS: COMPLAINT INVESTIGATION IDENTIFIED THAT INSUFFICIENT INFORMATION HAD BEEN PROVIDED TO VERIFY THE REPORTED INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS AND A SEARCH OF THE COMPLAINTS DATABASE IDENTIFIED NO KNOWN ANOMALIES WITH THE PRODUCTS AND NO KNOWN TRENDS OF THE PRODUCT LOTS USED IN THIS PROCEDURE. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED; THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    REVISED DUE TO PAIN. PATIENT HAS OSTEOARTHRITIS. PATIENT IS STABLE AFTER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123581 PFC SIGMA FEM POST AUG SZ4 4MM FEMORAL POST AUGMENT JWH DEPUY ORTHOPAEDICS E1JBK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention