BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SERIES I ACET. INSERT 10 26 MM ID

    MDR report key: 2499713 · Received March 19, 2012

    Report

    Report Number
    2249697-2012-00327
    Event Type
    Injury
    Date Received
    March 19, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS - MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K900438
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: C-TAPER COCR LFIT HEAD 26 MM/+10, CAT#: 06/2610, LOT#: 20296302. SECUR-FIT HA HIP STEM, CAT#: 1051-0830, LOT#: UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT HAD A REVISION SURGERY TO REPLACE THE HEAD AND INSERT DUE TO AN INSERT WEAR. WHEN THE SURGEON DISSOCIATED THE HEAD FROM THE STEM, HE NOTICED THE METAL DUST IN THE HEAD. THE SURGEON REPLACED THE HEAD AND INSERT AND COMPLETED THE REVISION SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT SERIES I ACET. INSERT 10 26 MM ID IMPLANT JDI STRYKER ORTHOPAEDICS - MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention