BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3962172 · Received July 28, 2014

    Report

    Report Number
    1818910-2014-24290
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 18, 2014
    Report Date
    September 15, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS - 1219
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.THE STEM HAS NOT BEEN REVISED. THE DOR FOR THE STEM WAS SUBMITTED IN ERROR.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. ASR REVISION REPORTED VIA SALES REP, RIGHT, REASON(S) FOR REVISION : PAIN AND RESORPTION OF CALCAR. UPDATE REC¿D 7/16/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS OSTEOLYSIS. UPON REVISION, YELLOW FLUID, FIBRINOUS TAN DEBRIS WITHIN THE POSTERIOR ASPECT OF THE FEMORAL HEAD, AND CORROSION ON THE TRUNNION WERE NOTED. THE SLEEVE IS NOW BEING REPORTED. STEM REMAINED IN SITU, AND IS BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 07/28/2014. UPDATE REC¿D 07/25/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 08/05/2014. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS 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.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP; RIGHT; REASON(S) FOR REVISION : PAIN AND RESORPTION OF CALCAR. UPDATE REC¿D (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS OSTEOLYSIS. UPON REVISION, YELLOW FLUID, FIBRINOUS TAN DEBRIS WITHIN THE POSTERIOR ASPECT OF THE FEMORAL HEAD, AND CORROSION ON THE TRUNNION WERE NOTED. THE SLEEVE IS NOW BEING REPORTED. STEM REMAINED IN SITU, AND IS BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439839 S-ROM*STM STD,42 NK,18X13X160 HIP FEMORAL STEM/SLEEVE JDI DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS - 1219 2362080

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR