BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 9254902 · Received October 30, 2019

    Report

    Report Number
    1818910-2019-113046
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 3, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295033950
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> THE HEAD AND THE LINER WERE RETURNED FOR INVESTIGATION. THE MODE OF FAILURE OF THE PROSTHESIS IS MULTI-FACTORIAL AND, WHILE THE STEEP SHELL ABDUCTION ANGLE MAY BE A CONTRIBUTORY FACTOR, CONSIDERATION HAS TO BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS, SURGICAL PROCESS, PATIENT VARIABLES E.G. ACTIVITY, WEIGHT, BMI AND USE, ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR BOTH THE HEAD AND THE LINER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A WORLDWIDE COMPLAINT SEARCH IDENTIFIED NO PREVIOUS COMPLAINTS FOR THE LINER (121936152, LOT 8792317) BUT DID FIND ONE PREVIOUS COMPLAINT FOR THE HEAD (136553000, LOT 8793894). THE PREVIOUS HEAD COMPLAINT WAS FOR INFECTION AND NO PRODUCT DEFECT WAS NOTED AND IS NOT RELATED TO THE EVENT IN THIS COMPLAINT. THE PRODUCTS SHALL BE RETAINED FOR FUTURE REFERENCE 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. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). 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

    THIS COMPLAINT IS RELATED TO A PATIENT THAT UNDERWENT TO SURGERY IN OCTOBER 2018 WITH A SECOND HIP PROSTHESIS, AFTER THE FIRST PROSTHESIS WAS IMPLANTED IN (B)(6) 2018. THE PATIENT FELT A SNAP IN A PARTICULAR MOVEMENT THAT WAS MADE A MONTH AFTER PLACING THE PROSTHESIS, THEN BEGAN TO FEEL A NOISE IN THE HIP AREA. RELATIVELY RECENTLY THE PATIENT VISITED THE SURGEON WHO PERFORMED A NEW RX AND FOUND THAT THE HIP PROSTHESIS WAS DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051677 ARTICULEZE M HEAD 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 8793894 10603295033950

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention