BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE IMPLANT

    MDR report key: 9130955 · Received September 27, 2019

    Report

    Report Number
    1818910-2019-106651
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    January 1, 2012
    Report Date
    September 16, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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). 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

    LITERATURE ARTICLE ENTITLED "MID-TERM SURVIVAL FOLLOWING PRIMARY HINGED TOTAL KNEE REPLACEMENT IS GOOD IRRESPECTIVE OF THE INDICATION FOR SURGERY" LITERATURE ARTICLE "MID-TERM SURVIVAL FOLLOWING PRIMARY HINGED TOTAL KNEE REPLACEMENT IS GOOD IRRESPECTIVE OF THE INDICATION FOR SURGERY" BY PAUL BAKER, REBECCA CRITCHLEY, ANDREW GRAY, SIMON JAMESON, PAUL GREGG, ANDREW PORT, AND DAVID DEEHAN PUBLISHED BY KNEE SURG SPORTS TRAUMATOL ARTHROSC 10.1007/S00167-012-2305-Y WAS REVIEWED FOR MDV REPORTABILITY. THE ARTICLE PURPOSE: THIS ARTICLE REPORTS THE RATES OF IMPLANT SURVIVAL, MODES OF FAILURE, REVISION DETAILS, AND FUNCTIONAL OUTCOMES WITH PARTICULAR REFERENCE TO THE PRIMARY INDICATION FOR SURGERY FOR A COHORT OF PATIENTS TREATED WITH PRIMARY HINGED KNEE REPLACEMENT. THE ARTICLE REPORTS: SYSTEMATIC REVIEW WITH SUPPLEMENTARY ANALYSIS USING DATA FROM THE NATIONAL JOINT REGISTRY AND DEPARTMENT OF HEALTH. ANALYSIS INCLUDED 964 PATIENTS UNDERGOING PRIMARY HINGED KNEE REPLACEMENT BETWEEN APRIL 2003 AND DECEMBER 2010. IN TOTAL, 20 CASES REQUIRED REVISION. OUT OF THESE 20, ONE 40-YEAR-OLD FEMALE PATIENT WAS FOUND TO PRESENT WITH ASEPTIC LOOSENING WITH A DEPUY PRODUCT ONLY 0.4 YEARS POST-OPERATION. DEPUY PRODUCT INVOLVED: NOILES ROTATING HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925836 UNKNOWN KNEE IMPLANT KNEE IMPLANT JWH DEPUY ORTHOPAEDICS, INC. 1818910 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention