BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +5

    MDR report key: 3222450 · Received July 12, 2013

    Report

    Report Number
    1818910-2013-21027
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    July 4, 2013
    Report Date
    January 16, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. . BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES BY THE MANUFACTURING SUPPLIER FINDS METAL TRANSFER ON THE BEARING SURFACE OF THE CERAMIC BALL HEAD AND A WEAR PATCH CLOSE TO THE RIM OF THE METAL INSERT INDICATE AN EDGE LOADING SITUATION OR RECURRING SUBLUXATIONS BETWEEN THE CERAMIC BALL HEAD AND THE METAL INSERT. AN EDGE-LOADING SITUATION OR RECURRING SUBLUXATIONS, CAN LEAD TO A LOSS OF FLUID FILM LUBRICATION BETWEEN THE CERAMIC BALL HEAD AND THE METAL INSERT AND A SUBSEQUENT INCREASE OF FRICTION, WHICH FINALLY INDUCES METAL WEAR AS WELL AS METAL TRANSFER ON THE BALL HEAD POTENTIALLY LEADING TO INCREASED COBALT AND CHROMIUM LEVELS AS REPORTED BY THE CUSTOMER. REVIEW OF DEVICE HISTORY RECORDS AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS OF THE CERAMIC BALL HEAD ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT. ADDITIONAL EVENT INFORMATION AND INVESTIGATIONAL INPUTS WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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

    REVISION THR FOR PAIN, RADIO GRAPHIC LYSIS, AND ELEVATED COBALT AND CHROMIUM, CERAMIC ON METAL 36MM CORAIL PINNACLE HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322234 DELTA CER HEAD 12/14 36MM +5 HEADBALL LZO DEPUY IRELAND 9616671 182591

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention