BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL BASEPLATE

    MDR report key: 6088786 · Received November 9, 2016

    Report

    Report Number
    0002249697-2016-03537
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 11, 2016
    Report Date
    January 12, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN UNKNOWN BASEPLATE WAS REPORTED. THE MEDICAL REVIEW CONFIRMED LOOSENING AND BASEPLATE MALPOSITION. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR TIBIAL SLOPE IN COMBINATION WITH SUBOPTIMAL CEMENTATION TECHNIQUE HAVE CONTRIBUTED TO AN OVERLOAD CONDITION AT THE BASEPLATE IMPLANT-BONE INTERFACE RESULTING IN LOOSENING AFTER AN UNKNOWN TIME REQUIRING REVISION. -DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE LOT IS UNKNOWN. -COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE LOT IS UNKNOWN. CONCLUSIONS: BASED ON THE PROVIDED MEDICAL REVIEW BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR TIBIAL SLOPE IN COMBINATION WITH SUBOPTIMAL CEMENTATION TECHNIQUE HAVE CONTRIBUTED TO AN OVERLOAD CONDITION AT THE BASEPLATE IMPLANT-BONE INTERFACE RESULTING IN LOOSENING AFTER AN UNKNOWN TIME REQUIRING REVISION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PER SALES REP, LEFT KNEE REVISION DUE TO PAIN AND INFLAMMATION. TIBIAL COMPONENT WAS LOOSE UPON INSPECTION. SCORPIO FEMORAL COMPONENT REMOVED, TIBIAL BASEPLATE, POLY AND PATELLA ALSO REMOVED. SIZES, CAT AND LOT NUMBERS ARE NOT KNOWN.

    Description of Event or Problem · 1

    PER SALES REP, LEFT KNEE REVISION DUE TO PAIN AND INFLAMMATION. TIBIAL COMPONENT WAS LOOSE UPON INSPECTION. SCORPIO FEMORAL COMPONENT REMOVED, TIBIAL BASEPLATE, POLY AND PATELLA ALSO REMOVED. SIZES, CAT AND LOT NUMBERS ARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741639 UNKNOWN TIBIAL BASEPLATE KNEE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R