BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V40 COCR LFIT HEAD 40MM/+0

    MDR report key: 1890693 · Received November 1, 2010

    Report

    Report Number
    2249697-2010-01447
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K061434
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. ADDITIONAL LOT# MJK9RA, MANUFACTURE DATE: (B)(4) 2010, EXP. DATE: 07/15/2015 AND STERILE LOT #MJK9RA.

    Description of Event or Problem · 1

    TOTAL HIP REPLACEMENT. A 62MM TRITANIUM CUP INSERTED, 40MM G LINER INSERTED. FEMORAL PREPARATION FOR 44 NO 1 EXETER STEM. REAL STEM INSERTED AND TRIAL FEMORAL HEAD USED. DEFINITIVE IMPLANT OPENED (40MM + 0M LIFT HEAD) AND PLACED ON TRUNION. TAPPED TO ENGAGE TAPER. IN TRYING TO RELOCATE JOINT THE HEAD DISENGAGED. TWO MORE ATTEMPTS AT ENGAGING HEAD, BUT IT WAS PULLED OFF AGAIN WITH MINIMAL FORCE. IDENTICAL HEAD ACQUIRED FROM (B)(6) AND OPENED WITH SAME RESULT. A 40 G LINER REMOVED AND 36 G 10 DEGREE HOODED LINER INSERTED. A 36MM CERAMIC +0MM HEAD USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 40MM/+0 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MHME22

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention