BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9420656 · Received December 5, 2019

    Report

    Report Number
    1818910-2019-121142
    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
    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).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. 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. 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

    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 PROSTHESES IN TKAS USING THE GAP BALANCING SURGICAL TECHNIQUE. DATA WAS COMPILED FROM 85 PATIENTS (108 KNEES) IMPLANTED BETWEEN DECEMBER 2000 TO JULY 2004. ALL PATIENTS 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 GENERAL ADVERSE EVENT WITHOUT PLATFORM IDENTIFIERS: LIMITED RANGE OF MOTION (TREATED BY MANIPULATION UNDER ANESTHESIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215109 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention