BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,36NK,18X13X160

    MDR report key: 3233420 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21544
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSERT, FEMORAL HEAD, AND FEMORAL STEM FINDS EVIDENCE TO SUGGEST STEM IMPINGEMENT. PATIENT X-RAYS WERE NOT PROVIDED, POSITIONING CANNOT BE COMMENTED ON. NO ABNORMAL WEAR PATTERNS OF THE ARTICULATING SURFACES ARE NOTED FROM VISUAL EXAMINATION. MATING WEAR IS FOUND CENTRALLY LOADED ON BOTH FEMORAL HEAD AND INSERT ARTICULATING SURFACE. ADDITIONAL EVENT INFORMATION AND INVESTIGATIONAL INPUTS WERE REQUESTED BUT NOT PROVIDED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER SIMILAR REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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 CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER SIMILAR REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED (B)(6) 2013 DUE TO HIGH METAL ION LEVELS, PAIN AND CYSTIC MASS IDENTIFIED BY MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335093 S-ROM*STM STD,36NK,18X13X160 HIP STEM JDI 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 2424924

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention