BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 2407832 · Received January 10, 2012

    Report

    Report Number
    1818910-2012-00768
    Event Type
    Injury
    Date Received
    January 10, 2012
    Date of Event
    April 20, 2011
    Report Date
    December 12, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 2765323 AND C31EA1000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2772133, 2812869, AND 2673247 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UDI: (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. 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: AGONIZING PAIN IN HIS GROIN, HIS INNER THIGH, AND HIS BUTTOCKS AREA AND HAD SEVERE DIFFICULTY WALKING OR MOVING IN GENERAL.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS, REVISION NOTES OF THE LEFT HIP REPORTED OF MEDICAL FRACTURE WHEN THE CUP WAS REMOVED.

    Description of Event or Problem · 1

    PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. ADDED ACCOUNT NAME, LAW FIRM, AGE AND WEIGHT OF PATIENT, GTIN OF LINER, HEAD AND CUP. ALSO ADDED SCREW AND STEM IN IMPACTED PRODUCT DUE TO ALLEGED LOOSENING AND ELEVATED METAL IONS. AT THIS TIME IT¿S UNKNOWN WHERE THE FRACTURE OCCURRED. IF/WHEN MORE INFORMATION IS RECEIVED, THE PC WILL BE UPDATED AS NEEDED. DOI: (B)(6) 2008 DOR: (B)(6) 2011 LEFT HIP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +8.5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2772133

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention