BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 10012403 · Received April 29, 2020

    Report

    Report Number
    1818910-2020-11523
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    January 3, 2019
    Report Date
    April 21, 2020
    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 · 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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR 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, 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 ¿DIABETES MELLITUS DOES NOT NEGATIVELY IMPACT OUTCOMES AND SATISFACTION FOLLOWING UNICOMPARTMENTAL KNEE ARTHROPLASTY IN WELL-CONTROLLED DISEASE¿, WRITTEN BY GIN WAY LAW PUBLISHED IN THE ASIA-PACIFIC JOURNAL OF SPORTS MEDICINE, ARTHROSCOPY, REHABILITATION AND TECHNOLOGY 16 (2019) 24-29, ON 3 JANUARY 2019, WAS REVIEWED. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE IMPACT OF DIABETES MELLITUS ON THE OUTCOMES AND SATISFACTION OF UKA AT TWO YEARS POSTOPERATIVELY. DEPUY PRODUCTS USED: PFC UKA. CEMENT MANUFACTURER NOT NOTED. THERE WERE 104 PATIENTS IN EACH GROUP (NON-DIABETES AND DIABETES). THERE WERE TWO IMPLANTS USED-A DEPUY IMPLANT AND A NON-DEPUY IMPLANT. IT WAS NOT SPECIFIED WHICH GROUP OR PATIENTS HAD WHICH IMPLANT. FOLLOW-UP WAS 2.8 YEARS. ADVERSE EVENTS: IN THE NON-DM GROUP, THERE WERE FIVE PATIENTS THAT HAD COMPLICATIONS, FOUR PATIENTS HAD SUPERFICIAL INFECTION (THREE TREATED WITH ORAL ANTIBIOTICS, ONE TREATED WITH INTRAVENOUS ANTIBIOTICS) AND ONE PATIENT HAD WOUND DEHISCENCE. IN THE DM GROUP, THERE WERE SIX PATIENTS THAT HAD COMPLICATIONS, FIVE PATIENTS HAD SUPERFICIAL INFECTION (ALL TREATED WITH ORAL ANTIBIOTICS), ONE PATIENT HAD WOUND DEHISCENCE AND ONE PATIENT HAD A STITCH ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475160 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention