BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX60OD

    MDR report key: 2071323 · Received April 13, 2011

    Report

    Report Number
    1818910-2011-06161
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    November 10, 2009
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    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 PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR AND METALLOSIS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: OVER TIME THE PT BEGAN TO SUFFER FROM SIGNIFICANT PAIN IN HIS LEFT HIP. HIS HIP DISLOCATED THREE TIMES IN THE NEXT FEW MONTHS, AND HIS DR DIAGNOSED HIM WITH A HIP IMPLANT FAILURE AND SCHEDULED A REVISION SURGERY. DURING THE REVISION SURGERY, THE DR OBSERVED THAT "A SIGNIFICANT AMOUNT OF FLUID WAS THEN OBTAINED, ALMOST LIKE A BURSAL TYPE FLUID, AND IT LOOKED ALMOST LIKE MACHINE OIL..." IT IS FURTHER ALLEGED THE FLUID THAT THE DR FOUND IS THE BIOLOGIC RESPONSE TO THE TOXIC METAL PARTICLES THAT ARE CAUSED BY A DEFECTIVE METAL-ON-METAL ARTICULATING SURFACE OF THE DEPUY PINNACLE HIP. IT IS ALSO ALLEGED THAT THE DR FOUND SIGNIFICANT DAMAGE TO THE PT'S SOFT TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX60OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US NA 1832458

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention