BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRH STANDARD AXLE

    MDR report key: 3762041 · Received April 21, 2014

    Report

    Report Number
    0002249697-2014-01422
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K792089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 6485-2-460, LOT LPTB864, DESCRIPTION: KRH DURATION BUSHING STANDARD X 2. CAT 6485-4-100, LOT LPTB842, DESCRIPTION: KRH DURATION STANDARD BUMPER. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A KRH STANDARD AXLE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT CONCLUDED. IN THIS LONG-TERM FOLLOW-UP OF SALVAGE TUMOR SURGERY, THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THE NOT UNEXPECTED CLINICAL PROBLEMS COMMON TO THIS TYPE OF ONCOLOGIC SURGERY. DEVICE HISTORY REVIEW. INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PAINFUL MRS TOTAL KNEE WITH XMR TIBIAL ALL POLY COMPONENT. PATIENT HAD ORIGINAL SURGERY IN ST. LOUIS IN THE 1990S. PATIENT WAS REVISED IN 1999 TO A CUSTOM MRS FEMUR SINCE SHE WAS TOO LONG. SHE WAS REVISED AGAIN FOR WORN BUSHINGS IN 2009 AND THEN SHE COMPLAINED OF PAIN RECENTLY. DOCTOR REVISED THE TIBIA TO A MRH COMPONENT AND REVISED THE FEMUR TO A GMRS. HE LEFT THE FEMORAL STEM IN PLACE AND REPLACED THE MRS CUSTOM WITH A GMRS PATIENT STABILITY WAS EXCELLENT. PATIENT HAD SOME POST SURGERY BLEEDING ISSUE REQUIRING A VASCULAR GRAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PAINFUL MRS TOTAL KNEE WITH XMR TIBIAL ALL POLY COMPONENT. PATIENT HAD ORIGINAL SURGERY IN (B)(6) IN THE 1990S. PATIENT WAS REVISED IN 1999 TO A CUSTOM MRS FEMUR SINCE SHE WAS TOO LONG. SHE WAS REVISED AGAIN FOR WORN BUSHINGS IN 2009 AND THEN SHE COMPLAINED OF PAIN RECENTLY. DOCTOR REVISED THE TIBIA TO A MRH COMPONENT AND REVISED THE FEMUR TO A GMRS. HE LEFT THE FEMORAL STEM IN PLACE AND REPLACED THE MRS CUSTOM WITH A GMRS PATIENT STABILITY WAS EXCELLENT. PATIENT HAD SOME POST SURGERY BLEEDING ISSUE REQUIRING A VASCULAR GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240160 KRH STANDARD AXLE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LTBRI4

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention