BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS TIB INSERT

    MDR report key: 3762046 · Received April 21, 2014

    Report

    Report Number
    0002249697-2014-01391
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    January 1, 2002
    Report Date
    August 24, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K033971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER RIGHT KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING FEMORAL COMPONENT LOOSENING INVOLVING A SCORPIO TIBIAL INSERT WAS REPORTED. CONCLUSION NO DEFICIENCY OF THE TIBIAL INSERT COMPONENT WAS ALLEGED; THE REVISION OPERATIVE REPORT INDICATES THE FEMORAL COMPONENT WAS GROSSLY LOOSE. THERE IS NO INDICATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT. THE FOLLOWING ADDITIONAL PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED: CAT. NO.: 71-4111R, SCORPIO PS FEMUR WAFFLE W/LFIT, LOT CODE: K01L274. CAT. NO.: 7115-0009, SERIES 7000 STANDARD TIBIA, LOT CODE: T01W240. CAT. NO.: 73-2910, SCORPIO C-DOME PATELLA, LOT CODE: K244. CAT. NO.: 6191-1-001, SIMPLEX P FULL DOSE 1 PACK, LOT CODE: RJI403.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING PAIN SINCE INITIAL SURGERY. PATIENT REPORTS HE WILL NEED A REVISION SURGERY.

    Description of Event or Problem · 1

    UPDATE PER PATIENT: PATIENT HAD REVISION SURGERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239696 SCORPIO PS TIB INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C MBH STRYKER ORTHOPAEDICS-MAHWAH 72140101

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R