BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD PLASMA HA STM 12MM X 167MMRESTORATION MODU

    MDR report key: 1620577 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00712
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 19, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS
    Product Code
    MEH
    PMA / PMN Number
    K013106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (USER RELATED CODE LZO).

    Description of Event or Problem · 1

    USER RELATED. IT WAS REPORTED THE SURGEON ATTEMPTED TO USE A STRYKER METAL HEAD WITH A DEPUY METAL LINER DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, THE SURGEON REALIZED THAT THE TWO COMPONENTS COULD NOT BE REDUCED AND THAT AS THE SURGEON HAD NO KNOWLEDGE OR TOOLS FOR THE REMOVAL OF THE LINER. THE PATIENT WAS CLOSED UP WITH THE FEMUR IN DISLOCATION. IT WAS FURTHER REPORTED THAT THE SURGEON OPERATED ON THE PATIENT AGAIN ON TUES 30TH JAN AND TOOK OUT THE TRIAL HEAD TO REPLACE IT WITH AN ALUMINA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOD PLASMA HA STM 12MM X 167MMRESTORATION MODU IMPLANT MEH STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS NA 10847502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention