BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA RP TC3 INSERT SIZE 3 MM 17.5

    MDR report key: 2122630 · Received June 8, 2011

    Report

    Report Number
    2122630
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 8, 2011
    Manufacturer
    DEPUY
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PT HAD ORIGINAL TOTAL KNEE REPLACEMENT IN 2003. PATIENT HAD A SUBSEQUENT TOTAL KNEE REVISION SEVERAL YEARS LATER. PATIENT RETURNED TO THE OR RECENTLY DUE TO LOOSENING OF PROSTHESIS. PHYSICIAN FELT THAT IMPLANTS LOOSENED QUICKLY AFTER HIS LAST REVISION SURGERY. COMPONENTS REMOVED AND ANTIBIOTIC SPACER IMPLANTED DUE TO SUSPECTED INFECTION (NEGATIVE CULTURES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA RP TC3 INSERT SIZE 3 MM 17.5 TIBIAL INSERT JWH DEPUY 96-2344 ZN3DA4000
    10 DEPUY 1 GENTAMICIN BONE CEMENT 40 G BONE CEMENT X2 LOD DEPUY 5450-31-500 2238499
    2 DEPUY ROUND DOME 3 POST 960111 PATELLA HTG DEPUY 96-0111 2380711
    3 DEPUY TIBIAL FLUTED ROD EXTENSION 20 X115 866433 TIBIAL FLUTED ROD EXTENSION JWH DEPUY 86-6433 304028R
    4 DEPUY KNEE FEMORAL COMPONENT SIZE 3 RIGHT 960088 KNEE FEMORAL COMPONENT JWH DEPUY 96-0088 077088AB
    5 DEPUY SIGMA FEMORAL ADAPTER 96-0781 FEMORAL ADAPTER JWH DEPUY 96-0781 BL5EK1000
    6 DEPUY SIGMA FEMORAL ADAPTER FEMORAL ADAPTER BOLT JWH DEPUY 96-0783 BJ7PT1000
    7 DEPUY PFC MODULAR KNEE SYSTEM FLUTED ROD JWH DEPUY 86-6418 338752R
    8 DEPUY TIBIAL TRAY JWH DEPUY 1294-35-130 BB6D61000
    9 DEPUY MBT STEP WEDGE SIZE 3 10MM MBT STEP WEDGE JWH DEPUY 1294-56-131 ZY4EY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R