BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9211478 · Received October 18, 2019

    Report

    Report Number
    1818910-2019-109531
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    January 1, 2012
    Report Date
    October 8, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: CORRECTED: H6 (DEVICE), H6. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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

    LITERATURE ARTICLE RECEIVED TITLED, " COMPUTER-NAVIGATED VERSUS CONVENTIONAL TOTAL KNEE ARTHROPLASTY" LITERATURE ARTICLE "COMPUTER-NAVIGATED VERSUS CONVENTIONAL TOTAL KNEE ARTHROPLASTY A PROSPECTIVE RANDOMIZED TRIAL" (2012) BY YOUNG-HOO KIM, MD, JANG-WON PARK, MD, AND JUN-SHIK KIM, MD PUBLISHED BY THE JOURNAL OF BONE AND JOINT SURGERY HTTP://DX.DOI.ORG/10.2106/JBJS.L.00142 WAS REVIEWED. THE ARTICLE PURPOSE: TO DETERMINE WHETHER COMPUTER NAVIGATED TOTAL KNEE ARTHROPLASTY IMPROVES THE CLINICAL FUNCTION, ALIGNMENT, AND SURVIVORSHIP OF THE COMPONENTS. THE ARTICLE REPORTS: THE RESULTS OF 520 PATIENTS WITH OSTEOARTHRITIS WHO UNDERWENT COMPUTER-NAVIGATED TOTAL KNEE ARTHROPLASTY FOR ONE KNEE AND CONVENTIONAL TOTAL KNEE ARTHROPLASTY FOR THE OTHER WERE COMPARED USING MULTIPLE CLINICAL MEASURES. DEPUY PFC SIGMA CR-MB PROSTHESIS WAS USED IN 400 KNEES AND A COMPETITOR PROSTHESIS WAS USED IN 640 KNEES. THE DATA DEMONSTRATED NO DIFFERENCE IN CLINICAL FUNCTION OR ALIGNMENT AND SURVIVORSHIP OF THE COMPONENTS BETWEEN THE KNEES THAT UNDERWENT COMPUTER-NAVIGATED TOTAL KNEE ARTHROPLASTY AND THOSE THAT UNDERWENT CONVENTIONAL TOTAL KNEE ARTHROPLASTY. THERE WERE TWO REPORTED DEEP INFECTIONS, BUT THE AUTHORS DID NOT DISCLOSE IN WHICH PRODUCT THESE WERE FOUND. DEPUY PRODUCTS INVOLVED: PFC SIGMA CR-MB. COMPLICATIONS: ASEPTIC LOOSENING OF TIBIAL COMPONENT (6), SURGICAL INTERVENTION (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005482 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention