BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9354486 · Received November 21, 2019

    Report

    Report Number
    1818910-2019-115765
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    February 12, 2015
    Report Date
    October 31, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. 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

    LITERATURE ARTICLE "EVALUATION OF ANTERIOR KNEE PAIN IN A PS TOTAL KNEE ARTHROPLASTY: THE ROLE OF PATELLA-FRIENDLY FEMORAL COMPONENT AND PATELLAR SIZE" (2015) BY F. ATZORI, L. SABATINI, D. DELEDDA, M. SCHIRO`, R. L. BAIDO, A. MASSE PUBLISHED BY MUSKULOSKELETAL SURGERY DOI 10.1007/S12306-015-0347-2 WAS REVIEWED. THE ARTICLE PURPOSE: TO EVALUATE WHETHER THE PATELLA-FRIENDLY FEMORAL COMPONENT CAN REDUCE THE ONSET OF ANTERIOR PATELLAR PAIN COMPARED TO A STANDARD FEMORAL COMPONENT AND ALSO TO DETERMINE WHETHER THESE PROBLEMS ORIGINATE FROM INDEXES AND MEASUREMENTS THAT ARE MANAGEABLE IN THE OPERATING ROOM. THE ARTICLE REPORTS: THIRTY CONSECUTIVE PATIENTS AFFECTED BY KNEE OSTEOARTHRITIS WITH SIMILAR CLINICAL CHARACTERISTICS WERE IMPLANTED USING PFC SIGMA IMPLANTS. THE FIRST 15 PATIENTS (GROUP 1) WERE TREATED USING SIGMA CS FEMORAL COMPONENT AND THE SECOND 15 PATIENTS USING THE NEW SIGMA PS FEMORAL KNEE COMPONENT (GROUP 2). THE SURGICAL TECHNIQUE WAS IDENTICAL IN EACH CASE OF THE TWO SUBGROUPS. THE TWO GROUPS DID NOT STATISTICALLY DIFFER ON ANY REPORTED METRIC EXCEPT THE PATIENTS WITH SMALL PATELLAR COMPONENTS SHOWED WORSE RESULTS FOR THE PATELLO-FEMORAL QUESTIONNAIRE. CEMENT WAS USED FOR THE FIXATION OF ALL COMPONENTS IN EVERY CASE. THE PATELLA WAS RESURFACED WITH A POLYETHYLENE SYMMETRIC DOME IN EVERY CASE. NO SURGICAL INTERVENTION WAS MENTIONED REGARDING THE PATELLA CLUNK. DEPUY PRODUCTS INVOLVED: PFC SIGMA CS SYSTEM. COMPLICATIONS: PATELLA CLUNK (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154541 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1