BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9628991 · Received January 24, 2020

    Report

    Report Number
    1818910-2020-02895
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    July 19, 2016
    Report Date
    January 15, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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 ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL 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 ENTITLED, ¿IMPLANT DESIGN AND EFFECTS ON PATELLOFEMORAL CREPITUS¿ BY DAVID CLINTON MCNABB, MD., ET AL, PUBLISHED BY JOURNAL OF KNEE SURGERY (2017), VOL. 30, PP. 863-871, WAS REVIEWED. THIS STUDY COMPARED THE INCIDENCE OF PATELLOFEMORAL CREPITUS BETWEEN TWO DEPUY PFC SIGMA TKA DESIGNS IMPLANTED IN 1120 KNEES BETWEEN JANUARY 2005-AUGUST 2010. IMPLANTED DEPUY PRODUCTS: PFC SIGMA PS AND PFC SIGMA HP PS. THE AUTHORS USED 931 MOBILE BEARINGS AND 189 FIXED BEARINGS. THE MANUFACTURER OF THE CEMENT IS UNKNOWN. RESULTS: THERE WERE 8 REVISIONS OF UNKNOWN COMPONENTS EXCLUDED FROM THE STUDY- 3 FOR ARTHROFIBROSIS, 4 FOR INFECTION, AND 1 FOR INSTABILITY. THERE WAS INSUFFICIENT INFORMATION PROVIDED TO ATTRIBUTE THE REVISIONS TO SPECIFIC COMPONENTS. 80 CASES OF SURGEON IDENTIFIED, ASYMPTOMATIC CREPITUS REQUIRING NO INTERVENTION OR TREATMENT. 55 CASES OF PATIENT IDENTIFIED CREPITUS REQUIRING NO TREATMENT OR INTERVENTION. THERE WERE AN UNKNOWN NUMBER OF PATIENT REPORTS OF DECREASED JOINT RANGE OF MOTION AND JOINT STIFFNESS. 25 CASES OF OPERATIVE CREPITUS TREATED WITH ARTHROSCOPIC OR OPEN DEBRIDEMENT OF THE FIBROSYNOVIAL PROLIFERATION. THE OPERATIVE CREPITUS WAS ATTRIBUTED TO PATELLA BAJA, A MISPOSITIONED FEMORAL COMPONENT, AND A DECREASE IN PATELLAR COMPONENT COMPOSITE THICKNESS. IMPACTED PRODUCTS: KNEE FEMORAL: PATELLAR CLUNK, IMPLANT MALPOSITION. KNEE PATELLA: IMPLANT BEARING WEAR AND IMPLANT NOISE (CLUNK). TIBIAL INSERT AND TIBIAL TRAY: NO REPORTED PRODUCT PROBLEM. HARMS: SURGICAL INTERVENTION AND MEDICAL DEVICE REMOVAL. SYMPTOMS: JOINT CREPITATION, JOINT INSTABILITY, MEDICAL DEVICE SITE JOINT RANGE OF MOTION DECREASED, INFECTION, AND SCAR TISSUE. THE JOINT CREPITATION, PAIN, AND MEDICAL DEVICE SITE JOINT RANGE OF MOTION DECREASED IS ATTRIBUTED TO THE FEMORAL AND PATELLAR COMPONENTS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91101 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention