BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 13769753 · Received March 15, 2022

    Report

    Report Number
    1818910-2022-04686
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    January 27, 2005
    Report Date
    March 15, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295033899
    PMA / PMN Number
    K980513
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 136550000, LOT 1193201 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. H10 ADDITIONAL NARRATIVE: ADDED: E3 INITIAL REPORTER OCCUPATION: LAWYER.

    Description of Event or Problem · 0

    PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INSTABILITY, SUBLUXATION, CLUNKING OF THE HIP. OPERATIVE NOTE REPORTED THE HIP WAS SUBLUXING ANTERIORLY. THERE WAS SOME EXCESSIVE LONGITUDINAL INSTABILITY OF THE HIP, SEROUS DRAINAGE WAS ENCOUNTERED IN THE HIP JOINT AND SOME EXCESSIVE ANTEVERSION. SHORTENING WAS PERFORMED RESULTED TO SOME ANTERIOR INSTABILITY. DOI: (B)(6) 2005;DOR: (B)(6), 2005; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696463 ARTICULEZE M HEAD 36MM -2 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 1365-50-000 1193201 10603295033899

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention PINN CAN BONE SCREW 6.5MMX30MM| PINNACLE MTL INS NEUT36IDX56OD| PINNACLE SECTOR II CUP 56MM| SUMMIT POR TAPER SZ7 STD OFF