BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICUL/EZE BALL 32 +17 WH

    MDR report key: 3052083 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-15198
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 17, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK883460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    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

    THIS IS A DUPLICATE REPORT OF 181910-2013-16307. THIS REPORT, 181910-2013-15198. WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-16307.

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE INSERT AND REPORTED BONE SCREWS. A REVIEW OF THE BONE SCREW DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INSERT IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW PER PROCEDURE. NO OTHER REPORTS WERE FOUND AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. X-RAYS AND MEDICAL RECORDS WERE RECEIVED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PSEUDOTUMOR AND METALOSIS.

    Description of Event or Problem · 1

    UPDATE 04/17/2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS ADVERSE LOCAL TISSUE REACTION, PAIN, AND OSTEOLYSIS, AND INCREASED COBALT AND CHROMIUM LEVELS. UPON REVISION A CLOUDY FLUID FILLED CYST AND NECROTIC TISSUE WAS FOUND. SCREWS WERE ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PSEUDOTUMOR AND METALLOSIS. UPDATE: (B)(6) 2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS ADVERSE LOCAL TISSUE REACTION, PAIN, AND OSTEOLYSIS, AND INCREASED COBALT AND CHROMIUM LEVELS. UPON REVISION A CLOUDY FLUID FILLED CYST AND NECROTIC TISSUE WAS FOUND. SCREWS WERE ADDED TO THE COMPLAINT. UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. UPDATE REC'D (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. AFTER REVIEW OF THE REVISION OPERATIVE NOTE IT INDICATED BLACK-STAINED NECROTIC TISSUE. IT ALSO INDICATED A LEG LENGTH DISCREPANCY SO THE STEM IS NOW BEING REPORTED. PART AND LOT INFORMATION IS BEING ADDED FOR THE ONE REPORTED SCREW AND ANOTHER SCREW IS BEING ADDED TO ADDRESS PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155414 ARTICUL/EZE BALL 32 +17 WH FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2074261

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention