BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SROM STEM

    MDR report key: 3250379 · Received July 26, 2013

    Report

    Report Number
    1818910-2013-22247
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    August 25, 2010
    Report Date
    June 27, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THE PATIENT WAS PRIMARILY IMPLANTED ON (B)(6) 2009 AND THE FIRST STAGE OF THE REVISION WAS PERFORMED IN (B)(6) 2010. IT IS NOT LIKELY THE DEVICE CONTRIBUTED TO THE PATIENTS REPORTED INFECTION MORE THAN A YEAR AFTER IMPLANTATION. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM (B)(6). CONFIRMED REVISION OF RIGHT PINNACLE/SROM IMPLANTS. REVISION DUE TO ONGOING PAIN AND INFECTION. TWO STAGE REVISION - 1ST STAGE (B)(6) 2010, 2ND STAGE (B)(6) 2010. UPDATE NOV 30, 2017: ADDITIONAL INFORMATION RECEIVED. THERE IS NO NEW INFORMATION ADDED. THIS COMPLAINT WAS UPDATED ON: DEC 4, 2017 THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    REVISION DUE TO ONGOING PAIN AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350977 UNKNOWN SROM STEM HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention