BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/0

    MDR report key: 1620569 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00670
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    December 13, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK STRYKR ORTHOPAEDICS
    Product Code
    KWY
    PMA / PMN Number
    K010757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008, WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (REVISION SURGERY REQUIRED AND PRODUCT CODE KWY).

    Description of Event or Problem · 1

    REVISION SURGERY REQUIRED. IT WAS REPORTED THAT "PATIENT TEMPLATED FOR A 2.5 STEM AND A 54MM CUP. AFTER REAMING THEY REQUIRED A 62 CUP, BUT THE SIZE WAS NOT AVAILABLE AS THE TOTE WITH THE BIGGER SIZES WAS NOT THERE. THEY USED A (B) (4) 62MM CUP AND STRYKER LFIT V40 36MM HEAD AND 2.5 ACCOLADE STEM. THEY WENT BACK INTO SURGERY THE SAME DAY AND REVISED THE HIP TO A CERAMIC HEAD AND ACCOLADE #3 STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 36MM/0 IMPLANT KWY STRYKER ORTHOPAEDICS CORK STRYKR ORTHOPAEDICS NA MJNMMA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention