BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT CEMENTED STEM SZ4 HI

    MDR report key: 2113059 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08786
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    February 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K013352
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS 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 COMBINATION WAS 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS CUP LOOSENING/SPIN-OUT. UPDATE: (B)(6) 2011 - OPERATIVE REPORT RECEIVED INDICATING THAT THE STEM WAS LOOSE. ADDITIONALLY IT WAS REPORTED THAT THE PATIENT HAD A SLIGHT ELEVATION OF INFLAMMATORY MARKERS. REPORTED DOR: (B)(6) 2011 COMPLAINT REOPENED TO ADD PRODUCT. UPDATE: (B)(6) 2012 LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED PAIN, DECREASED RANGE OF MOTION, LOSS OF ENJOYMENT OF LIFE, AND ELEVATED BLOOD LEVELS OF COBALT AND CHROMIUM. THERE WAS NO ADDITIONAL INFORMATION RECEIVED THAT WOULD IMPACT THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR FEMORAL STEM. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS CUP LOOSENING/SPIN-OUT. OPERATIVE REPORT RECEIVED INDICATING THAT THE STEM WAS LOOSE. ADDITIONALLY IT WAS REPORTED THAT THE PT HAD A SLIGHT ELEVATION OF INFLAMMATORY MARKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT CEMENTED STEM SZ4 HI TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. NA BE8DSA000

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention