BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT28IDX48OD

    MDR report key: 2250805 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18180
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K002883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR ELEVATED METAL IONS FOR BOTH REPORTED PART AND LOT NUMBER COMBINATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO ELEVATED METAL IONS, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM PAIN AND DIFFICULTY AMBULATING. IT IS ALSO ALLEGED THAT THE CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED. THE CUP HAS BEEN ADDED AND INITIAL EMDR CREATED.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP REPLACEMENT SECONDARY TO ACETABULAR WEAR. REVISION NOTE STATED, A CLOUDY NONPURULENT FLUID WAS OBTAINED IN THE HIP CAPSULE. THERE WAS SOME BLACK SYNOVIUM NOTED, HOWEVER, NO METALLOSIS AND NECROSIS WAS SEEN. THE CUP WAS SOLIDLY FIXED, HENCE, THIS WAS NOT REMOVED. CLINIC VISITS REPORTED HER SERUM CHROMIUM IS 56 (NO UNIT PROVIDED), POSSIBLE ALVAL TYPE OF REACTION, ALWAYS HAS SOME SQUEAKING ISSUES AND DISCOMFORT. TISSUE FROM LEFT HIP SYNOVIUM ALSO DISPLAYS BLUE-GRAY DISCOLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT28IDX48OD ACETABULAR LINER KWA DEPUY ORTHOPAEDICS INC US YGK73

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention