BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX56OD

    MDR report key: 2122639 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09866
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    January 19, 2012
    Report Date
    May 6, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. 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

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS STILL UNDER INVESTIGATION.

    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. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE 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.

    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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: FOR A YEAR OR SO PATIENT'S HIP IMPLANT DID WELL. BUT SEVERAL YEARS AFTER THE INITIAL SURGERY, HE BEGAN TO NOTICE PAIN AND BURNING IN HIS HIP AND GROIN AREA. HIS DOCTOR PRESCRIBED PAIN MEDICATIONS WHICH SEEMED TO HELP WITH SOME OF THE HIP PAIN BUT NOT ALL. SINCE THEN, PATIENT'S PAIN HAS CONTINUED TO INCREASE AND HE CONTINUES TO HAVE EXCRUCIATING PAIN. HE IS NOT ABLE TO AMBULATE WITHOUT A CANE. AS A RESULT, PATIENT HAS BEEN ON DISABILITY AND HAS NOT BEEN ABLE TO RETURN TO WORK. BECAUSE HE IS UNABLE TO WORK, HE IS WITHOUT MEDICAL INSURANCE AND HAS BEEN UNABLE TO OBTAIN MEDICAL OPINIONS NECESSARY TO DETERMINE WHETHER OR NOT REVISION SURGERY IS APPROPRIATE.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL ION LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX56OD TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS, INC. 1818910 NA 1955740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention