BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 X3 INSERT 23 MM ID

    MDR report key: 2307524 · Received October 19, 2011

    Report

    Report Number
    2249697-2011-01494
    Event Type
    Injury
    Date Received
    October 19, 2011
    Date of Event
    March 9, 2011
    Report Date
    September 22, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS - MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED BY STRYKER ORTHOPAEDICS CLINICAL AFFAIRS DEPT. NO ADD'L INFO IS AVAILABLE AT THIS TIME. ADD'L FOLLOW-UP INFO MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SITE INDICATED: "OPERATIVE SITE EVENT AS OTHER: OCC. RIGHT THIGH PAIN. POST-OPERATIVE, NO HISTORY OR CAUSATIVE EVENT, DEVICE RELATED AS UNCERTAIN: JAD DID NOT DO EXAM PERFORMED BY GLS IN PRACTICE, SERIOUSNESS MARKED AS NONE OF THE ABOVE. THERE WAS NO TREATMENT, FORM IS UNRESOLVED AS OF (B)(6) 2011."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 X3 INSERT 23 MM ID IMPLANT LPH STRYKER ORTHOPAEDICS - MAHWAH NA K8TMND

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention