BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II INSERT-10 DEG.

    MDR report key: 3381129 · Received October 2, 2013

    Report

    Report Number
    0002249697-2013-03175
    Event Type
    Injury
    Date Received
    October 2, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K943054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING AN OMNIFIT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. IT IS UNKNOWN WHY THE PRODUCT WAS NOT RETURNED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REVISION OF PRIMARY TOTAL HIP ARTHROPLASTY. REMOVAL OF 2041-2850 AND 06-2810 IMPLANTED IN 1994. REPLACED WITH 06-3210 AND 2043C-3250 DUE TO ECCENTRIC POLY WEAR.

    Description of Event or Problem · 1

    REVISION OF PRIMARY TOTAL HIP ARTHROPLASTY. REMOVAL OF 2041-2850 AND 06-2810 IMPLANTED IN 1994. REPLACED WITH 06-3210 AND 2043C-3250 DUE TO ECCENTRIC POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496970 OMNIFIT SER. II INSERT-10 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R