BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 8619360 · Received May 17, 2019

    Report

    Report Number
    1818910-2019-93790
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    November 4, 2009
    Report Date
    April 25, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    UDI-DI
    10603295033950
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE:  H6 PATIENT CODE: NO CODE AVAILABLE (3191) WAS USED TO CAPTURE TENDON INJURY AND DEVICE REVISION OR REPLACEMENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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 : 2932394. DEVICE HISTORY REVIEW : A PREVIOUS DEVICE HISTORY RECORD (DHR) REVIEW ON LEGACY COMPLAINT (B)(4) FOUND NO ANOMALIES.

    Description of Event or Problem · 0

    (B)(6) 2009: PERI-PROSTHETIC FEMUR FRACTURE WITH STEM SUBSIDENCE AND NON-UNION OF FEMUR FRACTURE. A COMPLETE ABDUCTOR TENDON AVULSION. STEM WAS NOTED TO BE RETROVERTED, CONSISTENT WITH ITS SUBSIDED, LOOSE STATE. THE ENTIRE ABDUCTION MECHANISM WAS AVULSED FROM THE ANTERIOR FEMUR. THE ABDUCTOR TENDON WAS REPAIRED. FEMORAL HEAD AND STEM WERE REVISED TO A COMPETITOR STEM AND A NEW DEPUY FEMORAL HEAD.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL "ATTORNEY". (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEVICE HISTORY LOT ==> 2932394. DEVICE HISTORY REVIEW ==> A PREVIOUS DEVICE HISTORY RECORD (DHR) REVIEW ON LEGACY COMPLAINT (B)(4) FOUND NO ANOMALIES. 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.

    Description of Event or Problem · 1

    PPF AND MEDICAL RECORD RECEIVED. PPF ALLEGES LOOSENING OF CUP, DISLOCATION, LOOSENING OF STEM AND FRACTURE BONE AND COMPONENT. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS FEMUR FRACTURE AND FEMORAL SUBSIDENCE WITH TROCHANTERIC NONUNION AND COMPLETE ABDUCTOR TENDON AVULSION. DOI: (B)(6) 2009. DOR: (B)(6) 2009 (LEFT HIP) SECOND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412267 ARTICULEZE M HEAD 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS, INC. 1818910 1365-53-000 2932394 10603295033950

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention