BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,42 NK,18X13X160

    MDR report key: 3382000 · Received October 2, 2013

    Report

    Report Number
    1818910-2013-29200
    Event Type
    Injury
    Date Received
    October 2, 2013
    Date of Event
    September 4, 2013
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    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. ONE OTHER REPORT WAS FOUND IN A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE 1842457 LOT CODE FOR INFECTION. THE REPORTS ARE NOT SIMILAR AS THERE IS NO REFERENCE TO METAL ON METAL ISSUES. BECAUSE NO REASON FOR REVISION HAS BEEN REPORTED, ANY CORRELATION CANNOT BE DETERMINED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINING 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. 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

    INFORMATION RECEIVED FROM (B)(6). POSSIBLE REVISION OF PINNACLE/SROM MOM IMPLANTS. REASON NOT PROVIDED, REVISION DATE NOT CONFIRMED. RIGHT SIDE 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

    INFORMATION RECEIVED FROM KENNEDY'S. POSSIBLE REVISION OF PINNACLE/SROM MOM IMPLANTS. REASON NOT PROVIDED, REVISION DATE NOT CONFIRMED. RIGHT SIDE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497796 S-ROM*STM STD,42 NK,18X13X160 HIP FEMORAL STEM/SLEEVE JDI DEPUY IRELAND 9616671 1864723

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention