BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9212563 · Received October 20, 2019

    Report

    Report Number
    1818910-2019-110814
    Event Type
    Malfunction
    Date Received
    October 20, 2019
    Date of Event
    January 1, 2014
    Report Date
    October 10, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE WAS RECEIVED ENTITLED "PATELLAR CLUNK SYNDROME IN FIXED-BEARING POSTERIOR-STABILISED VERSUS CRUCIATE-SUBSTITUTING PROSTHESES". LITERATURE ARTICLE "PATELLAR CLUNK SYNDROME IN FIXED-BEARING POSTERIOR-STABILISED VERSUS CRUCIATE-SUBSTITUTING PROSTHESES" (2014) BY YAN HO TANG, WING KEUNG WONG, AND HOK LEUNG WONG PUBLISHED BY JOURNAL OF ORTHOPAEDIC SURGERY WAS REVIEWED. THE ARTICLE PURPOSE: TO COMPARE THE OUTCOME OF FIXED-BEARING POSTERIOR-STABILISED VERSUS CRUCIATE-SUBSTITUTING PROSTHESES IN 46 PATIENTS WHO UNDERWENT PRIMARY BILATERAL TOTAL KNEE REPLACEMENT. THE ARTICLE REPORTS: AT ONE YEAR, THE MEAN FIXED FLEXION CONTRACTURE, MAXIMUM FLEXION, AND AMERICAN KNEE SOCIETY SCORES IN KNEES WITH PFC CS AND COMPETITOR PROSTHESES WERE COMPARABLE. THREE KNEES WITH THE PFC CS PROSTHESIS DEVELOPED THE PATELLAR CLUNK SYNDROME, COMPARED TO NONE WITH THE COMPETITOR PRODUCT. THE ONSET OF THE PATELLAR CLUNK SYNDROME WAS AROUND ONE YEAR AFTER SURGERY. ALL THREE PATIENTS WERE MANAGED CONSERVATIVELY. DESPITE THIS, THE AXIAL ALIGNMENT AND ROTATION OF THE FEMORAL AND TIBIAL COMPONENTS WERE GOOD. THE AUTHORS REPORT THAT BOTH OUR PFC SIGMA CS AND THE COMPETITOR PRODUCT BOTH PRODUCED GOOD CLINICAL OUTCOMES OVERALL. THE PATELLA WAS ROUTINELY RESURFACED AND CEMENT USAGE OR MANUFACTURER WERE NOT MENTIONED WITHIN THE ARTICLE. DEPUY PRODUCTS INVOLVED: PFC SIGMA CS. COMPLICATIONS: PATELLA CLUNK SYNDROME (3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006785 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1