BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG CR FEMORAL COMPONENT WITH HA SIZE 4

    MDR report key: 2142413 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00918
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE EVENT INVOLVES SCORPIO NRG CR FEMORAL COMPONENT WITH HA THAT IS NOT CLEARED FOR COMMERCIAL DISTRIBUTION IN THE U.S., HOWEVER, THE REPORTED EVENT IS RELATED TO A "MANIPULATION UNDER ANAESTHETIC", WHICH MAY OCCUR WITH CEMENTED SCORPIO NRG CR FEMORAL COMPONENT.

    Description of Event or Problem · 1

    PER RAISED WITH MINIMAL INFORMATION: THE CUSTOMER DAVID SCARLE REPORTED THAT A REVISION TOOK PLACE UNDER A CLINICAL TRIAL. HE COMPLETED AN SAE REPORT (SERIOUS ADVERSE EVENT - NOT NECESSARILY RELATED TO PRODUCT) WITH THE FOLLOWING INFO: "ROUTINE TKR, PREOP 5-110 ROM, INITIALLY 5-100, THEN AT 1 YEAR RANGE HAD SLIPPED TP 30-90." IT WAS ALSO STATED IN THE REPORT THAT THE ACTION TAKEN WAS A "MANIPULATION UNDER ANAESTHETIC", THAT THE SEVERITY WAS CLASSED AS "MILD", THAT THE PT WAS NOW "RECOVERING" AND A RELATIONSHIP TO DEVICE WAS FOUND TO BE "UNLIKELY". NOTE: PRODUCT CODE WAS NOT AVAILABLE AND WILL BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG CR FEMORAL COMPONENT WITH HA SIZE 4 IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention