BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10 X 3 INSERT 36MM ID

    MDR report key: 1903526 · Received November 16, 2010

    Report

    Report Number
    9616680-2010-00742
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR #2249697-2010-01545.

    Description of Event or Problem · 1

    IMPLANT SURGEON MR. INFORMED SALES REP MR. THAT LINER DID NOT LOCK INTO TRITANIUM ACETABULUM CPU. PRIMARY OPERATION WAS DONE BY SURGEON MR (B)(6) ON (B)(6) 2010 AND IMPLANTS WERE (B)(4) LOT MJD65W, (B)(4) LOT 34177601 AND (B)(4) LOT MHKE8K. REVISION WAS DONE (B)(6) AS PT HAD PAIN. REVISION WAS MADE BY SURGEONS. IN THIS OPERATION NOTICED THAT THE LINER WAS NOT LOCKED INTO TRITANIUM CUP. NEW LINER (B)(4) LOT 33478501 WAS TRIED TO USE BUT DID NOT LOCKED IN. ALL PRODUCTS TOOK AWAY AND INSERTED NEW: (B)(4) LOT MJH674, (B)(4) LOT 34268201 AND (B)(4) LOT 34818503.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10 X 3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS CORK NA 33478501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention