BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9420665 · Received December 5, 2019

    Report

    Report Number
    1818910-2019-121146
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    July 17, 2015
    Report Date
    November 14, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, ""TEN YEAR FOLLOW-UP OF GAP BALANCED, ROTATING PLATFORM TOTAL KNEE ARTHROPLASTY IN PATIENTS UNDER 60 YEARS OF AGE"" WRITTEN BY JASON H. LEE, MD, STEVEN L. BARNETT, MD, JAY J. PATEL, MD, NADER A. NASSIF, MD, DENNIS J. CUMMINGS, MD AND ROBERT S. GORAB, MD PUBLISHED BY THE JOURNAL OF ARTHROPLASTY 31 (2016) 132-136 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO EVALUATE THE MID TO LONG TERM CLINICAL OUTCOME IN PATIENTS YOUNGER THAN SIXTY YEARS OF AGE WHO UNDERWENT RP PROSTEHSES IN TKAS USING THE GAP BALANCING SURGICAL TECHNIQUE. DATA WAS COMPILED FROM 85 PATIENTS (108 KNEES) IMPLANTED BETWEEN DECEMBER 2000 TO JULY 2004. ALL PATEINTS RECEIVED DEPUY PRODUCTS. THE CEMENT MANUFACTURER WAS NOT IDENTIFIED AND PATELLA RESURFACING WAS NOT PERFORMED DURING INITIAL IMPLANTATION. THE ARTICLE PROVIDES A TABLE OF 3 REVISION CASES WITH IDENTIFIED PLATFORMS ASSOCIATED WITH SPECIFIC ADVERSE EVENTS AND THEY ARE CAPTURED IN LINKED COMPLAINTS. DEPUY PRODUCTS UTILIZED: SIGMA RP AND LCS COMPLETE SYSTEMS. THIS COMPLAINT CAPTURES CASE 3 WITH A SIGMA RP IMPLANT AND REASON FOR FAILURE WAS ASEPTIC FEMORAL COMPONENT LOOSENING WITH AN UNRESURFACED PATELLA 45 MONTHS POST OP. TREATMENT WAS SINGLE STAGED COMPONENT REVISION OF TIBIAL COMPONENT, FEMORAL COMPONENT AND PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213326 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention