BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9329888 · Received November 15, 2019

    Report

    Report Number
    1818910-2019-116505
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    October 6, 2016
    Report Date
    October 29, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED "PATELLOFEMORAL JOINT ARTHROPLASTY: OUR EXPERIENCE IN ISOLATED PATELLOFEMORAL AND BICOMPARTMENTAL ARTHRITIC KNEES". LITERATURE ARTICLE "PATELLOFEMORAL JOINT ARTHROPLASTY: OUR EXPERIENCE IN ISOLATED PATELLOFEMORAL AND BICOMPARTMENTAL ARTHRITIC KNEES" (2016) BY L. SABATINI , M. SCHIRÒ , F. ATZORI , G. FERRERO AND A. MASSÈ PUBLISHED BY CLINICAL MEDICINE INSIGHTS: ARTHRITIS AND MUSCULOSKELETAL DISORDERS DOI: 10.4137/CMAMD.S40498 WAS REVIEWED. THE ARTICLE PURPOSE: TO EVALUATE THE AUTHORS FIRST EXPERIENCE WITH PFR ARTHROPLASTY AND ITS COMBINATION WITH UNICOMPARTMENTAL KNEE ARTHROPLASTY. THE ARTICLE REPORTS: FROM MAY 2014 TO MARCH 2016, THE AUTHORS TREATED 15 KNEES IN 14 PATIENTS. THE DEPUY SIGMA UNICOMPARTMENTAL AND TROCHLEA IMPLANTS. NO PATIENTS WERE LOST DURING THE FOLLOW-UP. FOR ALL PATIENTS, THEIR KSS SCORES IMPROVED SIGNIFICANTLY. AT THE CLINICAL EXAMINATION DURING FOLLOW-UP, THE AUTHORS OBSERVED A COMPLICATION IN ONLY ONE CASE, WHO SUFFERED FROM PES ANSERINUS TENDINITIS (TENDON INJURY) AND EXPERIENCED A PAINLESS PATELLAR CLUNK. THE AUTHORS HAVE A TABLE LISTING PATIENTS BY AGE/GENDER, ALTHOUGH IT IS NOT INDICATED WHICH OF THESE PATIENTS SUFFERED THE COMPLICATIONS MENTIONED. FOR THE SAKE OF ASSUMING THE "WORST-CASE" WE WILL ASSUME THE PATIENT WAS WITHIN THE GROUP WITH BOTH THE PFA AND THE UKA. NO TREATMENT REGARDING EITHER OF THESE COMPLICATIONS IS MENTIONED. PATELLA RESURFACING IS ROUTINELY CONDUCTED. CEMENT USAGE IS NOT NOTED. DEPUY PRODUCTS INVOLVED: SIGMA TROCHLEAR AND UNICOMPARTMENTAL IMPLANTS. COMPLICATIONS: PATELLA CLUNK (1), TENDON INJURY (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120436 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1