BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 4251048 · Received November 14, 2014

    Report

    Report Number
    1818910-2014-31737
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    August 15, 2014
    Report Date
    November 6, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). DEPUY ORTHOPAEDICS IS PROVIDING THE FOLLOWING INFORMATION, AS DEPUY ORTHOPAEDICS DID NOT MANUFACTURE, OR IMPORT, THE FOLLOWING DEVICE(S): MANUFACTURER: UNKNOWN COMPETITOR ACETABULAR CUP AND FEMORAL STEM. EVENT: THIS WAS USED IN CONJUNCTION WITH DEPUY PRODUCT IN THIS PATIENT.

    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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT/LOT COMBINATIONS SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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 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 DUE TO INFECTION. UNKNOWN COMPETITOR'S ACETABULAR CUP AND FEMORAL STEM WERE USED IN CONJUNCTION WITH DEPUY PRODUCTS.

    Description of Event or Problem · 1

    UPDATE REC'D 11/06/2014 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. THE MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. RECORDS INDICATE THE PATIENT HAD IMPLANTED AT THE TIME OF REVISION A DEPUY CUP AND FEMORAL STEM. THE PATIENT'S ACETABULAR CUP AND SCREWS ALONG WITH FEMORAL STEM AND BONE CEMENT ARE BEING ADDED TO THE COMPLAINT AT THIS TIME FOR INFECTION. THE COMPLAINT WAS UPDATED ON: 11/25/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738525 ARTICULEZE M HEAD 36MM +5 HIP FEMORAL HEAD JDI DEPUY IRELAND 9616671 7842909

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention