BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL INSERT SIGMA

    MDR report key: 15417812 · Received September 14, 2022

    Report

    Report Number
    1818910-2022-17883
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    July 7, 2019
    Report Date
    September 14, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    ARTICLE ENTITLED ¿COMPARISON OF PATIENT-REPORTED OUTCOMES BASED ON IMPLANT BRAND IN TOTAL KNEE ARTHROPLASTY "WRITTEN BY C. A. KAHLENBERG, S. LYMAN, A. D. JOSEPH, Y-F. CHIU, D. E. PADGETT, PUBLISHED BY THE BONE & JOINT JOURNAL ON DATE WAS REVIEWED. THE ARTICLES PURPOSE WAS TO EVALUATE THE PATIENT-REPORTED OUTCOMES AND SATISFACTION AFTER PRIMARY TKA IN PATIENTS WITH OSTEOARTHRITIS UNDERGOING PRIMARY TKA USING FIVE DIFFERENT BRANDS OF POSTERIOR-STABILIZED IMPLANT. USING OUR INSTITUTIONAL REGISTRY, WE IDENTIFIED 4135 PATIENTS WHO UNDERWENT TKA USING ONE OF THE FIVE MOST COMMON BRANDS OF IMPLANTS. 222 OF THE 4135 WERE DEPUY. S. PATIENTS WERE EVALUATED PREOPERATIVELY USING THE KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS), LOWER EXTREMITY ACTIVITY SCALE (LEAS), AND 12-ITEM SHORT-FORM HEALTH SURVEY QUESTIONNAIRE (SF-12). DEMOGRAPHICS INCLUDING AGE, BODY MASS INDEX, CHARLSON COMORBIDITY INDEX, AMERICAN SOCIETY OF ANESTHESIOLOGISTS STATUS, SEX, AND SMOKING STATUS WERE COLLECTED. POSTOPERATIVELY, TWO-YEAR KOOS, LEAS, SF-12, AND SATISFACTION SCORES WERE COMPARED BETWEEN GROUPS. OUTCOMES WERE AVAILABLE FOR 4069 PATIENTS AT TWO YEARS POSTOPERATIVELY. IN MULTIPLE REGRESSION ANALYSIS, WHICH SEPARATELY COMPARED EACH IMPLANT GROUP WITH THE AGGREGATE OF ALL OTHERS, THERE WERE NO CLINICALLY SIGNIFICANT DIFFERENCES IN THE CHANGE OF KOOS SCORE FROM BASELINE TO TWO-YEAR FOLLOW-UP BETWEEN ANY OF THE GROUPS. MORE THAN 80% OF PATIENTS IN EACH GROUP WERE SATISFIED AT THIS TIME IN ALL DOMAINS. IN A MULTIVARIATE REGRESSION MODEL, PATIENTS IN THE NEXGEN GROUP WERE THE MOST LIKELY TO BE SATISFIED (ODDS RATIO (OR) AND OPTETRAK LOGIC PATIENTS WERE THE LEAST LIKELY TO BE SATISFIED. A TOTAL OF 79 PATIENTS REPORTED THAT THEY HAD REQUIRED FURTHER PROCEDURES OR SURGERY ON THEIR KNEE IN THE INITIAL SIX MONTHS FOLLOWING SURGERY. 2 OF THE REVISIONS WERE DEPUY KNEES, WITH NO FURTHER INFORMATION PROVIDED AS TO THE REASON FOR THE REVISION, NOR WHAT WAS REVISED. THE STUDY REVIEWED PATIENT¿S PAIN, STIFFNESS, AND ADL¿S. THERE WERE NO TREATMENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746492 UNK KNEE TIBIAL INSERT SIGMA KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention