BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 4914810 · Received July 15, 2015

    Report

    Report Number
    1818910-2015-25682
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 11, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. ¿ REG. # 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT WAS REVISED TO ADDRESS A DISLOCATION.

    Description of Event or Problem · 1

    UPDATE REC'D 07/28/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, UPON ENTERING THE HIP CAPSULE THERE WAS A MODERATE AMOUNT OF TISSUE ENCOUNTERED THAT WAS CONSISTENT WITH POLY WEAR. ALSO NOTED, THE POLYETHYLENE WAS CLEARLY NOT SEATED IN THE SHELL. THE CUP WAS FOUND TO QUITE VERTICAL AND ANTEVERTED. AFTER REMOVING THE FEMORAL HEAD THERE WAS A BLACKENED TRUNNION. AT THIS TIME THE PATIENT'S CUP IS BEING ADDED TO THE COMPLAINT AND REPORTED. THE COMPLAINT WAS UPDATED ON: 08/21/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458912 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. ¿ REG. # 8010379 2229877

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention