BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 10092746 · Received May 27, 2020

    Report

    Report Number
    1818910-2020-12634
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    January 9, 2019
    Report Date
    May 18, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION 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. 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. 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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 ¿ARMD REACTION PATTERNS IN KNEE ARTHROPLASTY. A NOVEL HYPOTHETICAL MECHANISM: HINGIOSIS¿, WRITTEN BY NIKLAS KIRCHEN, ET AL, PUBLISHED IN THE ORTHOPEDIST, 9 JANUARY 2019, WAS REVIEWED. THE PURPOSE OF THE STUDY WITHIN THE ARTICLE WAS THE SYMPTOMATIC HISTOPATHOLOGICAL ANALYSIS OF ADVERSE TISSUE REACTIONS IN NON-INFECTIOUS KEP FAILURE USING THE EXPANDED SLIM CONSENSUS CLASSIFICATION, THE PARTICLE ALGORITHM, THE ALVAL SCORE AND THE CD3 SCORE. DEPUY PRODUCTS USED: PFC SIGMA. THERE WERE FIVE CASE DESCRIPTIONS; ONLY ONE WAS A DEPUY PRODUCT. ADVERSE EVENT WITH PATIENT ONE, (B)(6) FEMALE: DECREASED ROM AND ADHESIONS; AFTER 12 YEARS THE PATIENT UNDERWENT REPLACEMENT OPERATION SECONDARY TO SYNOVITIS AND SUSPECTED PE CONSUMPTION. INTRAOPERATIVELY, PE CONSUMPTION WAS DETECTED MACROSCOPICALLY WHICH WAS INTERPRETED AS THE STARTING POINT FOR THE METALLIC ABRASION. THERE WAS ALSO PE WEAR OF THE INLAY WHICH CAUSING THE METALLIC BASE SUPPORT PLATES TO COME INTO CONTACT WITH ONE ANOTHER. THE PATIENT ALSO SCORED 10/10 ALVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556155 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention