BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 2233879 · Received September 6, 2011

    Report

    Report Number
    1818910-2011-17128
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 25, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED INTO THE (B)(4) QUALITY DEPARTMENT (B)(4) 2011. FOLLOWING RECEIPT OF PRODUCTS, THE COMPLAINT WAS TRANSFERRED TO BIOENGINEERING FOR INVESTIGATION (B)(4) 2011. ROOT CAUSE: UNDETERMINED, IT IS NOT POSSIBLE TO CONFIRM THAT THE IMPLANT POSITION AS NO X-RAYS ARE PROVIDED AND THIS MAY BE ONE CAUSE OF THE DISLOCATION. SOME EDGE WEAR OF THE BEARING IS SUGGESTED ON THE LINER REDLUX IMAGE. HEAD/STEM DISASSOCIATION IS REPORTED WITH 9/10 AND 12/14 TAPERS AT A LOW RATE. IT IS NOT POSSIBLE TO SAY IF THE HEAD DISASSOCIATED FROM THE TAPER FIRST OR THE HEAD FROM THE LINER. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED; THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    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

    THE PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX52OD HIP KWA DEPUY INTERNATIONAL 2479634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention