BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 9MM CR INSERT

    MDR report key: 6993315 · Received November 1, 2017

    Report

    Report Number
    0002249697-2017-03169
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    October 4, 2017
    Report Date
    January 4, 2018
    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

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ROM ISSUES INVOLVING A TRIATHLON TIBIAL INSERT WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH MEDICAL REVIEW. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE INSPECTION WAS NOT PERFORMED AS NO DEVICES WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING: TOTAL KNEE ARTHROPLASTY REQUIRING EXTENSILE EXPOSURE HAS RESULTED IN ARTHROFIBROSIS WITH IMPAIRMENT OF KNEE FUNCTIONALITY. AN EXTENSIVE SCAR TISSUE RELEASE WAS PERFORMED IN COMBINATION WITH LINER EXCHANGE AS REQUIRED FOR ADEQUATE EXPOSURE AND TO RESTORE ADEQUATE STABILITY OF THE ARTHROPLASTY AFTER THE PROCEDURE. DEVICE HISTORY REVIEW: NOT PERFORMED AS LOT DETAILS WERE NOT PROVIDED. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: THE MEDICAL REVIEW INDICATES TOTAL KNEE ARTHROPLASTY REQUIRING EXTENSILE EXPOSURE HAS RESULTED IN ARTHROFIBROSIS WITH IMPAIRMENT OF KNEE FUNCTIONALITY. AN EXTENSIVE SCAR TISSUE RELEASE WAS PERFORMED IN COMBINATION WITH LINER EXCHANGE AS REQUIRED FOR ADEQUATE EXPOSURE AND TO RESTORE ADEQUATE STABILITY OF THE ARTHROPLASTY AFTER THE PROCEDURE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION SUCH AS DEVICE DETAILS AND DEVICE RETURN, X-RAYS AND OPERATIVE NOTES BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INABILITY TO REACH FULL FLEXION. SURGEON EXPLANTED A 9MM CR INSERT, PERFORMED A DEBRIDEMENT AND SOFT TISSUE RELEASE. WITH AN ORTHO SENSOR, SURGEON BALANCED THE KNEE AND IMPLANTED A 9MM CS INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INABILITY TO REACH FULL FLEXION. SURGEON EXPLANTED A 9MM CR INSERT, PERFORMED A DEBRIDEMENT AND SOFT TISSUE RELEASE. WITH AN ORTHO SENSOR, SURGEON BALANCED THE KNEE AND IMPLANTED A 9MM CS INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773314 UNKNOWN 9MM CR INSERT KNEE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R