BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 2211809 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14478
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 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

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED COBALT SERUM LEVELS AND THE CUP POSITION WAS REPORTED TO BE SLIGHTLY ELEVATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED COBALT SERUM LEVELS AND THE CUP POSITION WAS REPORTED TO BE SLIGHTLY ELEVATED. THE LINER AND HEAD WERE REMOVED, BUT NOT THE CUP. UPDATE - 11/14/2011 - LITIGATION PAPERS ALLEGE SUBSEQUENT TO SURGERY, PATIENT SUFFERED NEUROLOGICAL PROBLEMS SUCH AS DIZZINESS, FATIGUE, NAUSEA, AND HEADACHE. IT IS ALSO ALLEGED HIS BLOOD WORK REVEALED ELEVATED LEVELS OF COBALT AND CHROMIUM. THERE IS NO NEW PRODUCT INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE 2/6/2017 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, LAB LEVELS INDICATED THE METAL ION LEVELS WERE BELOW 7PPB. THE MEDICAL RECORDS INDICATED A SLIGHTLY VERTICAL CUP, BUT THERE WAS NO MENTION OF IT DURING THE REVISION OPERATIVE NOTE AND IT WASN'T REVISED. PAIN WAS ALSO REPORTED. THE PRIMARY OPERATION INDICATED AN 800ML BLOOD LOSS, BUT NO COMPLICATIONS WERE NOTED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX58OD 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 1222439

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention