BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 10313919 · Received July 23, 2020

    Report

    Report Number
    1818910-2020-16658
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    September 18, 2018
    Report Date
    July 16, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 CODE(S) 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. CORRECTIVE ACTION WAS NOT INDICATED.

    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, "TOTAL KNEE ARTHROPLASTY IN SEVERE VALGUS DEFORMITY USING A MODIFIED TECHNIQUED A 10-YEAR FOLLOW-UP STUDY" WRITTEN BY ADAM TUCKER, MB, MRCS, MPHIL, SEAMUS O'BRIEN, PHD, EMER DORAN, BSC, DIPN, NICOLA GALLAGHER, PHD, DAVID E. BEVERLAND, MD, FRCS PUBLISHED BY THE JOURNAL OF ARTHROPLASTY MADE AVAILABLE ONLINE ON 18 SEPTEMBER 2018 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO REPORT RESULTS FROM A 10 YEAR FOLLOW UP OF A PREVIOUSLY REPORTED STUDY. THE PREVIOUS STUDY WAS REVIEWED AND REPORTED APPROPRIATELY UNDER (B)(4). THIS COMPLAINT WILL CAPTURE ANY NEWLY REPORTED ADVERSE EVENTS WITHIN THIS ARTICLE SINCE THE LAST STUDY'S ARTICLE ((B)(4)). CEMENT MANUFACTURER NOT IDENTIFIED. PATELLA RESURFACING WAS NOT PERFORMED IN ANY PATIENT. DEPUY PRODUCT: UNCEMENTED LCS FEMORAL, LCS INSERT, UNCEMENTED/CEMENTED LCS TIBIAL TRAY. ADVERSE EVENTS REPORTED FROM PREVIOUS STUDY (REFER TO (B)(4)): TRAY SUBSIDENCE (TREATED BY REVISION), INFECTION AND/OR HEMATOMA (TREATED BY WASHOUT ONLY), SPINOUT (TREATED BY CLOSED REDUCTION AND LONG-LEG PLASTER). ADVERSE EVENTS TO REPORT FROM THIS ARTICLE'S 10 YEAR FOLLOW UP DATA: PERIPROSTHETIC FRACTURE (FEMORAL, TREATED BY OPEN REDUCTION INTERNAL FIXATION OR IM NAIL) PUS IN KNEE (INFECTION CULTURE WAS NEGATIVE, TREATED BY WASHOUT ONLY, CONTINUES TO HAVE PAIN AT 10 YEAR FOLLOW UP). "KNEE STIFFNESS" (TREATED BY MANIPULATION UNDER ANESTHESIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776427 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention