BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12/14 ARTICUL 40MM M SPEC+1.5

    MDR report key: 2882626 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28527
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2012 - PATIENT'S MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. ADDITIONALLY NOTED THE PATIENT WAS BILATERAL. RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    (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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL 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, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER LEFT SIDE. PATIENT HAS LARGE AMOUNTS OF COBALT-CHROMIUM METAL IONS AND PARTICLES IN HER BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER LEFT THIGH AND GROIN. SHE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT. DOI: (B)(6) 2009 - DOR: UNK (LEFT SIDE). **PATIENT IS A RESIDENT OF (B)(6). **UPDATE** (B)(6) 2012 - PATIENT'S MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. ADDITIONALLY NOTED THE PATIENT WAS BILATERAL.

    Description of Event or Problem · 1

    THE STEM WAS ADDED TO THE IMPACTED PRODUCT DUE TO A LARGE AMOUNT OF TOXIC COBALT CHROMIUM IN THE PATIENT BLOOD. THE DOI WAS UPDATED AND CHANGE THE SIDE OF THE HIP THAT WAS REPORTED IN THE WPC TO THE RIGHT SIDE FROM LEFT SIDE. ADDED ASSOCIATED CONTACT AND LAW FIRM IN THE FACILITY NAME. THIS PC WILL ONLY ADDRESS THE RIGHT SIDE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40MM M SPEC+1.5 FEMORAL HEAD LPH DEPUY ORTHOPAEDICS, INC. 1818910 3150085

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention