BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 22D

    MDR report key: 2990434 · Received March 5, 2013

    Report

    Report Number
    0002249697-2013-00909
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW INDICATES THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. REVIEW INDICATED THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR THE REPORTED LOT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    THIRD DISLOCATION.

    Description of Event or Problem · 1

    THIRD DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93548 TRIDENT 0 DEG CONSTRAINED INSERT 22D IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH MLA5L0

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention