BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9489059 · Received December 18, 2019

    Report

    Report Number
    1818910-2019-123768
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    March 2, 2013
    Report Date
    December 3, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. 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. 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

    THE LITERATURE ARTICLE ENTITLED, "LESS OUTLIERS IN PINLESS NAVIGATION COMPARED WITH CONVENTIONAL SURGERY IN TOTAL KNEE ARTHROPLASTY" WRITTEN BY JERRY YONGQIANG CHEN, PAK LIN CHIN, DARREN KENG JIN TAY, SHI-LU CHIA, NGAI NUNG LO, AND SENG JIN YEO PUBLISHED BY KNEE SURGERY SPORTS TRAUMATOL ARTHROSCOPY (2014) 22: 1827-1832 DOI 10.1007/S00167-013-2456-5 PUBLISHED ONLINE 2 MARCH 2013 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO INVESTIGATE EFFECTIVENESS OF A NEW PINLESS NAVIGATION SYSTEM AS AN INTRA-OPERATIVE ALIGNMENT CHECK IN TOTAL KNEE ARTHROPLASTY USING CONVENTIONAL CUTTING JITS. DATA WAS COMPILED FROM 200 PATIENTS RECEIVING IMPLANTS BETWEEN MARCH 2011 AND AUGUST 2012. ALL IMPLANTS UTILIZED WERE DEPUY. CEMENT MANUFACTURER NOT IDENTIFIED. NO PATELLA RESURFACING WAS PERFORMED. DEPUY PRODUCTS UTILIZED: SIGMA FIXED BEARING KNEE SYSTEM ADVERSE EVENTS: 1 PATIENT WITH DEEP VEIN THROMBOSIS IN RIGHT PROXIMAL POSTERIOR TIBIAL VEIN (INTERVENTION NOT SPECIFIED), 1 PATIENT EXPERIENCED "FLUID OVERLOAD POST OPERATIVELY" (NO FURTHER INFORMATION OR DETAILS REGARDING THIS EVENT). ARTICLE PROVIDES INSUFFICIENT DETAILS OR CLARIFICATION REGARDING CLINICAL SYMPTOMS OR DIAGNOSIS OF "FLUID OVERLOAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286020 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention