BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI ADAPTOR SLEEVE C TAPER TI

    MDR report key: 2110160 · Received May 19, 2011

    Report

    Report Number
    9616680-2011-00323
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K070885
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON TRIALED THE -2.5 TRIAL C-TAPER HEAD ON THE SECURFIT STEM. THE HIP WAS REDUCED AND IT APPEARED TO BE FIRM AND STABLE. WHEN THE -2.5 ADAPTOR SLEEVE AND UNIVERSAL HEAD WAS IMPACTED ON THE STEM, AND THE HIP WAS REDUCED, THE HIP WAS UNSTABLE AND VERY LOOSE. SURGEON THEN PUT A +0 UNIVERSAL TAPER ON THE STEM WITH THE UNIVERSAL HEAD AND IT APPEARED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI ADAPTOR SLEEVE C TAPER TI IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 35961404

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other