BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTORATION ADM X3 INS 28/48

    MDR report key: 2181569 · Received July 18, 2011

    Report

    Report Number
    9616680-2011-00476
    Event Type
    Other
    Date Received
    July 18, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 MFR. ITEM WAS DISCARDED. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD A TRIDENT PSL 60MM CUP IMPLANTED. REP OPENED WRONG X3 INSERT AND IT WAS MATED WITH BIOLOX DELTA 28MM HEAD. AS PHYSICIAN STARTED TO IMPLANT THE LINER/CUP IT WAS REALIZED THAT THE WRONG LINER WAS BEING USED. IT WAS REMOVED AND THE CORRECT INSERT, 1236-2-854 AND BIOLOX HEAD WERE IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM X3 INS 28/48 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 35366501

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other