BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9212663 · Received October 20, 2019

    Report

    Report Number
    1818910-2019-110859
    Event Type
    Injury
    Date Received
    October 20, 2019
    Date of Event
    March 11, 2013
    Report Date
    October 14, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED "PATELLOFEMORAL CREPITUS IN HIGH FLEXION ROTATING PLATFORM KNEE ARTHROPLASTY." LITERATURE ARTICLE "PATELLOFEMORAL CREPITUS IN HIGH FLEXION ROTATING PLATFORM KNEE ARTHROPLASTY." BY MARK P. SHILLINGTON, KARA CASHMAN, AND GREG FARMER PUBLISHED BY ANZ JOURNAL OF SURGERY DOI: 10.1111/ANS.12173 WAS REVIEWED. THE ARTICLE PURPOSE: TO REPORT THE EARLY RESULTS OF THE LCS RPS TOTAL KNEE REPLACEMENT FROM BOTH A CLINICAL SERIES AND THE AUSTRALIAN ORTHPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY. THE ARTICLE REPORTS: BETWEEN MAY 2009 AND JUNE 2010, 69 PRIMARY TKRS WERE PERFORMED IN 62 PATIENTS USING A MOBILE BEARING POSTERIOR STABILIZED TKR (LCS- RP SYSTEM). IN NINE CASES, THE PATELLA WAS RESURFACED AS PART OF THE PRIMARY PROCEDURE, AND IN THE REMAINING 60 WAS NOT RESURFACED. SEVERE CREPITUS WAS IDENTIFIED IN 12 PATIENTS (21%), MODERATE CREPITUS IN 21 (37%), MILD CREPITUS IN 15 (26%) AND NO CREPITUS IN NINE (16%). A SECONDARY PROCEDURE WAS PERFORMED ON 17 KNEES IN 15 PATIENTS. WHEN CAUSE FOR REVISION IS CONSIDERED, 78.6% WERE DONE FOR PATELLOFEMORAL PAIN. NO PATIENTS WHO UNDERWENT PATELLA RESURFACING AS PART OF THE PRIMARY PROCEDURE DEVELOPED CREPITUS. DEPUY PRODUCTS INVOLVED: LCS- RP. COMPLICATIONS: CREPITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006792 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention