BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY LCS

    MDR report key: 1951123 · Received December 30, 2010

    Report

    Report Number
    MW5018848
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    September 14, 2009
    Report Date
    December 30, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CAN NOT BEND MY KNEE. SEVERE PAIN AND SWELLING. SKIN IRRITATION, VERY DRY SKIN AROUND KNEE. KNEE POPS IN AND OUT CAUSING ME TO FALL DOWN. DATES OF USE: (B)(6) 2009 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DEGENERATIVE JOINT DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY LCS LCS COMPLETE RP INSERT SZ STD MM 10 JWH DEPUY ORTHOPAEDICS, INC. DEIRN4000
    2 DEPUY, LCS COMPLETE PRIMARY FEMORAL FEMORAL JWH DEPUY ORTHOPAEDICS, INC. 2166261 2011-05
    3 DEPUY, LCS COMPLETE ALL POLY PATELLA PATELLA HTG DEPUY ORTHOPAEDICS, INC. 2900319 2014-04
    4 DEPUY MBT TIBIAL TRAY CEMENTED 3 TIBIAL TRAY HSX DEPUY ORTHOPAEDICS, INC. 2947484 2014-06
    5 SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT BONE CEMENT LOD STRYKER HOWMEDICA OSTEONICS RK0261

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R LOT# 2166261 (B)(4)