BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 2161162 · Received July 8, 2011

    Report

    Report Number
    2249697-2011-01029
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED FROM THE TERRITORY MANAGER INDICATED THAT THE PT HAD NO IMPLANT RECORDS. THE ORIGINAL STEM WAS LEFT IN-SITU. THE ORIGINAL CUP WAS REMOVED BUT THE IDENTITY OR THE CUP COULD NOT BE DETERMINED. IF ADDITIONAL INFO IS PROVIDED, THE EVAL RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HIP REVISION SURGERY WAS PLANNED FOR THIS PT. THE SURGEON HAD INFORMED US PRIOR TO SURGERY THAT THERE WAS A TRIDENT CUP AND ACCOLADE IN SITU AND THE PLAN WAS TO RE-POSITION THE CUP AND POSSIBLY CHANGE THE HEAD ON THE STEM. THERE WAS NO ACCESS TO PREVIOUS X-RAYS OR NOTES PRIOR TO SURGERY. IT WAS REPORTED THAT DURING THE SURGERY, IT WAS OBSERVED THAT IT WAS IN FACT A SMITH AND NEPHEW STEM AND HEAD IN SITU AND WITH NO ACCESS TO REPLACEMENT S+N HEADS, IT WAS DECIDED TO PLACE A STRYKER C-TAPER HEAD ON THE S+N STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CUP IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention