BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 22D

    MDR report key: 2142897 · Received June 22, 2011

    Report

    Report Number
    2249697-2011-00935
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO (INCLUDING X-RAYS, OPERATIVE REPORTS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "RECURRENT DISLOCATING PT. DISLOCATED HER PREVIOUS CONSTRAINED LINER. DOCTOR PROCEEDED WITH A ZIMMER IMPLEX SHELL AND CEMENTED IN THE ALL-POLY TRIDENT CONSTRAINED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG CONSTRAINED INSERT 22D IMPLANT KWZ STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention