BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2984618 · Received February 28, 2013

    Report

    Report Number
    0002249697-2013-00823
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING TIBIAL COMPONENT LOOSENING INVOLVING A SCORPIO TIBIAL BASEPLATE WAS REPORTED. THE EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED COMPONENT WAS UNREMARKABLE. THE DEVICE WAS IN GOOD CONDITION WITH NO GROSS DAMAGES NOTED. REVIEW OF THE PROVIDED REVISION OPERATIVE REPORTED CONFIRMED THE REPORTED TIBIAL COMPONENT LOOSENING. THE RECORDS WERE PRESENTED TO A CONSULTING CLINICIAN WHO DEEMED THEM INSUFFICIENT TO PROVIDE A MEANINGFUL DICTATION. POST-PRIMARY X-RAY IMAGES OF THE PATIENT'S KNEE WOULD BE REQUIRED TO COMMENT ON THIS CASE. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER EVENTS HAVE BEEN REPORTED FOR THE MANUFACTURING LOT. REVIEW OF THE PROVIDED REVISION OPERATIVE REPORTED CONFIRMED THE REPORTED TIBIAL COMPONENT LOOSENING; HOWEVER, THEY WERE INSUFFICIENT TO DETERMINE A ROOT CAUSE. X-RAY IMAGES OF THE IMPLANTED COMPONENTS WOULD BE REQUIRED TO EVALUATE THIS CASE.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TIBIAL TRAY. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REVISED A SCORPIO TOTAL KNEE DUE TO TIBIAL TRAY LOOSENING ON THE AFTERNOON OF (B)(6). SURGEON NOTED DURING CASE THAT THE TRAY DID NOT BOND TO CEMENT. PATIENT WAS REVISED TO A TRIATHLON TS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REVISED A SCORPIO TOTAL KNEE DUE TO TIBIAL TRAY LOOSENING ON THE AFTERNOON OF (B)(6) AT (B)(6) MEDICAL CENTER. SURGEON NOTED DURING CASE THAT THE TRAY DID NOT BOND TO CEMENT. PATIENT WAS REVISED TO A TRIATHLON TS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85969 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 5WLMPA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention