BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM*STM ST,36+8L NK,18X13X160

    MDR report key: 4090967 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-28064
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    September 1, 2013
    Report Date
    August 27, 2014
    Manufacturer
    DEPUY IRELAND
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE FEMORAL HEAD. PER PROCEDURE, THIS DEVICE IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. X-RAYS WERE REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS 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 INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES SEVERE PAIN AND OSTEOLYSIS. UPDATE RECEIVED (B)(4) 2014 - THE COMPLAINT HAS BEEN UPDATED BECAUSE IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO SIGNIFICANT OSTEOLYSIS. ACCORDINGLY, THE MDR DECISION IS BEING CHANGED FROM MDR-NO TO MDR-YES. THIS COMPLAINT WAS UPDATED (B)(4) 2014. UPDATE REC¿D (3/21/2014) - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM A PSEUDOTUMOR AND ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON : 4/17/2014. UPDATE REC'D 8/27/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED OSTEOLYSIS, PSEUDOTUMOR, AND CORROSION ON THE TRUNNION OF THE STEM. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 9/15/2014.

    Description of Event or Problem · 1

    UPDATE 2/26/16, 3/1/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. MEDICAL RECORDS NOTED PATIENT WAS HAVING ADVERSE REACTIONS TO THE COMPONENTS. REACTIONS WERE TO METAL DEBRIS, THERE WAS PROXIMAL FEMUR OSTEOLYSIS, OCCASIONAL SUBLUXATION EPISODES REPROTED BY PATIENT, GRINDING AT TIMES, AND SURGEON NOTED RIGHT LEG WAS LONGER THAN LEFT. REVISION SURGICAL REPORT NOTED 100ML BROWNISH FLUID, BROWN FRIABLE TISSUE, BLACK CORROSION AT TAPER AND PER MRI, THERE WAS OSSIFICATION AT THE SUPERIOR LATERAL MARGIN OF THE RIGHT HIP JOINT. METAL ION LAB RESULTS WERE LESS THAN 7 PARTS PER BILLION FOR CHROMIUM. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: MAR 8, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568536 SROM*STM ST,36+8L NK,18X13X160 HIP FEMORAL STEM JDI DEPUY IRELAND 1872990

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other