BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 12851203 · Received November 22, 2021

    Report

    Report Number
    1818910-2021-25900
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    November 2, 2021
    Report Date
    November 22, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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 · 0

    A DRRA STUDY, ¿MD HEMA RETROSPECTIVE REAL-WORLD EVIDENCE FINAL STUDY REPORT: (B)(6) ACTIS MERCY SINGLE ARM SURVIVAL ANALYSIS¿, BY JENNIFER WOOD MD, JACK MANTEL, TODD TETREAULT, ABHISHEK CHITNIS, KADE ETTER, JILL RUPPENKAMP, CHANTAL HOLY, LILIT HOVHANNISYAN. THE STUDY WAS A NON-INTERVENTIONAL, RETROSPECTIVE, OBSERVATIONAL COHORT STUDY OF EMR DATA TO OBTAIN BASELINE DATA AND CLINICAL OUTCOMES FOR PATIENTS WHO RECEIVED THE DEPUY ACTIS TOTAL HIP REPLACEMENT. THE STUDY REVIEWED DATABASE INFORMATION FROM A SINGLE HEALTH CARE SYSTEM, WHICH INCLUDED 44 HOSPITALS, 350 OUTPATIENT FACILITIES, AND 3000 INTEGRATED PROVIDERS. THE PATIENT DATASET WAS BASED ON MEDICAL BILLING AND DIAGNOSIS CODES ASSOCIATED WITH AN ORTHOPEDIC CONDITION AND INCLUDES APPROXIMATELY 800,000 TOTAL PATIENTS. THE ONLY KNOWN PROSTHESIS WAS THE ACTIS FEMORAL STEM. IT WILL BE ASSUMED THAT THE FEMORAL HEAD IS ALSO A DEPUY PRODUCT. IT IS NOT KNOWN WHICH HIPS MAY BE HYBRID HIPS, UTILIZING COMPETITOR SYSTEM CUPS AND LINERS. OUT OF 1252 PATIENTS WHO MET THE CRITERIA FOR INCLUSION, THE FOLLOWING COMPLICATIONS WERE REPORTED: GENERAL INFECTIONS (IN 24 MONTHS POST-OP): 51. SUPERFICIAL INFECTIONS (IN 24 MONTHS POST-OP): 22. DEEP INFECTIONS (IN 24 MONTHS POST-OP): 1. FRACTURES (IN 24 MONTHS POST-OP): 13. ASEPTIC LOOSENING (IN 24 MONTHS POST-OP): 2. HIP DISLOCATIONS (IN 24 MONTHS POST-OP): 7. HIP REVISION (IN 24 MONTHS POST-OP): 8. NON-REVISION SURGICAL INTERVENTIONS (IN 24 MONTHS POST-OP): 13. HIP CLOSED REDUCTION (IN 24 MONTHS POST-OP): 2. HIP INCISION & DRAINAGE NON-REVISION (IN 24 MONTHS POST-OP): 8. HIP IRRIGATION & DEBRIDEMENT NON-REVISION (IN 24 MONTHS POST-OP): 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747912 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention