BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL INSERT LCS

    MDR report key: 11247784 · Received January 28, 2021

    Report

    Report Number
    1818910-2021-02034
    Event Type
    Injury
    Date Received
    January 28, 2021
    Report Date
    January 25, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE TITLED, "CLINICAL AND RADIOLOGICAL OUTCOMES AFTER NAVIGATED TOTAL KNEE ARTHROPLASTY. ANALYSIS OF A CONTROLLED AND PROSPECTIVE STUDY COMPARED TO CONVENTIONAL IMPLANTATION TECHNIQUES" WRITTEN BY C. BERTSCH, U. HOLZ, G. KONRAD, A. VAKILI, AND M. OBERST PUBLISHED BY ORTHOPADE 2007 36:739-745 DOI 10.1007/S00132-007-1122-3 AND PUBLISHED ONLINE: JULY 20, 2007 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO ANALYZE INITIAL CLINICAL OUTCOMES OF A PROSPECTIVE AND CONTROLLED STUDY OF NAVIGATED VERSE NON-NAVIGATED IMPLANTATION IN KNEE ARTHROPLASTY. DATA WAS COMPILED FROM A TOTAL OF 71 PROSTHESES THAT WERE IMPLANTED IN 64 PATIENTS AND DIVIDED INTO TWO GROUPS. ONE GROUP CAPTURING RESULTS UTILIZING TRADITIONAL TECHNIQUES FOR PRIMARY IMPLANTATION AND THE OTHER GROUP USING THE NAVIGATED SYSTEM. CEMENT MANUFACTURER IS NOT IDENTIFIED AND PATELLAR RESURFACING IS NOT DISCUSSED. INITIAL RESULTS ARE THAT THE NAVIGATION SYSTEM REDUCES OVERALL AVERAGE OF VARUS/VALGUS DEVIATION FROM ANATOMICAL LONG LEG AXIS BUT ALSO REQUIRE A LONGER OPERATING TIME. THE ARTICLE CONCLUDES LONG-TERM FOLLOW UP MAY BE NEEDED FOR MORE CONCLUSIVE RESULTS. THE ARTICLE DOES NOT PROVIDE ADEQUATE INFORMATION TO DETERMINE EXACT QUANTITIES OF PRODUCTS INVOLVED AS PATIENTS CAN EXPERIENCE MORE THAN ONE ADVERSE EVENT. DEPUY PRODUCTS UTILIZED: LCS FEMORAL, LCS TIBIAL INSERT, LCS TIBIAL TRAY. ADVERSE EVENTS: DELAYED WOUND HEALING (11 CASES, NO FURTHER INFORMATION PROVIDED REGARDING TREATMENT) POSTOPERATIVE BLEEDING (TREATED BY SURGERY). SUBCUTANEOUS WOUND INFECTION (TREATED BY REVISION). TWO PATIENTS FELL IN REHAB (ONE FROM EACH GROUP) RESULTING IN WOUND DEHISCENCE (TREATED BY SECONDARY SUTURES). HYPOSENSITIVE AREA IN SCAR REGION (2 CASES IN TRADITIONAL PRIMARY GROUP, NO FURTHER INFORMATION PROVIDED REGARDING TREATMENT). PERONEAL NERVE PARALYSIS (1 CASE IN NAVIGATION GROUP, RESOLVED OVER TIME).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145490 UNK KNEE TIBIAL INSERT LCS KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention