BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 2232321 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15643
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 2812877 OR 2820706. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS TWO ADDITIONAL REPORTED INCIDENTS AGAINST THE LOT CODE 2748837 AND ONE ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2777228 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2009, PT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HIS RIGHT SIDE, AND ON (B)(6) 2009, PT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HIS LEFT SIDE. PT HAS LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES IN HIS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANTS. PT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS THIGHS AND GROIN. HE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINTS WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANTS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2009, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HIS RIGHT SIDE, AND ON (B)(6) 2009 PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HIS LEFT SIDE. PATIENT HAS LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES IN HIS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANTS. PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS THIGHS AND GROIN. HE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINTS WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANTS. UPDATE: (B)(6) 2012 - PATIENTS MEDICAL RECORDS WERE RECEIVED FROM LEGAL AND ARE LOCATED ON THE EXTERNAL HARD DRIVE. PART/LOT INFORMATION WAS IDENTIFIED.

    Description of Event or Problem · 1

    ADDED STEM DUE TO PREVIOUSLY ALLEGED LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS. ADDED PATIENT'S AGE AND LAWYER IN THE ASSOCIATED CONTACT.

    Description of Event or Problem · 1

    ADDED STEM DUE TO PREVIOUSLY ALLEGED LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS. ADDED PATIENT'S AGE AND LAWYER IN THE ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS, INC. 1818910  NA 2748837

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention