BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3102902 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01594
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TS BASEPLATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING OSTEOLYSIS INVOLVING AN UNKNOWN SCORPIO TS BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES AND THE RETURN OF THE DEVICES ARE NEEDED TO COMPLETE THE INVESTIGATION. IT ALSO CONCLUDED THAT THERE IS NO INDICATION THE EVENT IS RELATED TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WE TOOK OUT SCORPIO TS FEMUR AND SCORPIO TS BASEPLATE. THERE WAS SIGNIFICANT BONE LOSS ON FEMORAL SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WE TOOK OUT SCORPIO TS FEMUR AND SCORPIO TS BASEPLATE. THERE WAS SIGNIFICANT BONE LOSS ON FEMORAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203919 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention