BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEONICS OMNIFIT PSL HA ACETABULAR SHELL

    MDR report key: 213775 · Received March 10, 1999

    Report

    Report Number
    2243265-1999-00007
    Event Type
    Injury
    Date Received
    March 10, 1999
    Date of Event
    August 21, 1995
    Report Date
    February 10, 1999
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A MEETING WITH REP OF STRYKER EUROPE, SURGEONS FROM SWEDEN REPORTED A HIGH RATE OF REVISION WITH A PARTICULAR GROUP OF ACETABULAR COMPONENTS. THE REASONS FOR REVISION REPORTEDLY INCLUDED SHELL LOOSENING, INSERT WEAR AND/OR OSTEOLYSIS. THE INFO THAT WAS DISCUSSED APPEARS TO SPAN A PERIOD OF SEVERAL YEARS - FROM THE EARLY 1990'S TO THE PRESENT. THE CONVERSATIONS WERE GENERAL IN NATURE AND DID NOT FOCUS ON A SPECIFIC INCIDENT. FOLLOWING THE MEETINGS, THE SURGEONS SUBMITTED PRODUCT LABELS FROM MULTIPLE REVISION SURGERIES THAT WERE REPORTEDLY REPRESENTATIVE OF THE ISSUES THAT WERE DISCUSSED. NO OTHER SPECIFIC INFO WAS PROVIDED. REF MFR REPORT #'S 2243265-1999-00004 THRU 00015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEONICS OMNIFIT PSL HA ACETABULAR SHELL Implant ACETABULAR SHELL KWB HOWMEDICA OSTEONICS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention