BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,36NK,16X11X150

    MDR report key: 3517240 · Received December 12, 2013

    Report

    Report Number
    1818910-2013-35890
    Event Type
    Injury
    Date Received
    December 12, 2013
    Report Date
    November 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS AGAINST LOT CODE XX8DK1001, 1110490, 1071529, 898103 OR 1008865. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS AGAINST LOT CODE XX8DK1001, 1110490, 1071529, 898103 OR 1008865. X-RAYS WERE RECEIVED AND REVIEWED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF INFECTION. UPDATE: (B)(6) 2013 - PATIENT SEEKING LEGAL ACTION. PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE: LITIGATION PAPERS RECEIVED (B)(6) 2013. LITIGATION ALLEGES PAIN, DISCOMFORT, INFECTION, ELEVATED LEVELS OF COBALT AND CHROMIUM AND REPEATED DISLOCATIONS. IT IS ALSO ALLEGED THAT DURING THE REVISION, A SUBSTANTIAL AMOUNT OF FLUID WAS NOTED. THE MDR DECISION IS NOW BEING REVERSED AND ALL PRODUCTS REPORTED.

    Description of Event or Problem · 1

    PPF ALLEGES PSEUDOTUMOR AND FRACTURE (BONE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650199 S-ROM*STM STD,36NK,16X11X150 FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US 898103

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention