BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR

    MDR report key: 8490785 · Received April 8, 2019

    Report

    Report Number
    3004105610-2019-00043
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 11, 2019
    Report Date
    June 26, 2019
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA EXPIRATION 11/30/1989 TO 08/31/1995. PATIENT CODE FROM INFLAMMATION TO INJURY . MANUFACTURING DATE 05/25/1989 TO 02/09/1995. ADDITIONAL MANUFACTURER NARRATIVE AN EVENT REGARDING ALLEGED REBUSHING INVOLVING A PATIENT SPECIFIC DISTAL FEMUR WAS REPORTED. THE EVENT COULD NOT BE CONFIRMED RADIO- GRAPHICALLY. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. CLINICIAN REVIEW: THE X-RAY PROVIDED SHOWED THAT THE IMPLANT IN GOOD ALIGNMENT BETWEEN THE FEMORAL AND THE TIBIAL COMPONENTS AND THE TIBIAL STEM WAS VERY WELL FIXED. THERE IS NO SIGN OF LOOSENING FOR THE KNEE HINGE JOINT, THEREFORE THE REASON FOR REVISION CANNOT BE RADIOGRAPHICALLY CONFIRMED. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD INDICATE ONE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 09FEB1995, WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 10 OTHER EVENTS RELEVANT TO THIS INVESTIGATION. CONCLUSIONS: A REPORT WAS RECEIVED INDICATING THAT A DISTAL FEMUR REPLACEMENT IMPLANT THAT WAS IMPLANTED 20 YEARS AGO REQUIRES REBUSHING. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS PATIENT HISTORY AND FOLLOW UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. THE OPERATION WAS SCHEDULED FOR 18JUN2019; HOWEVER, NO PROCEDURE WAS PERFORMED ON THIS DATE. IF ANY INFORMATION BECOMES AVAILABLE AFTER THE SURGERY, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY SIW. IF DEVICES AND ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE RE-OPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    A PATIENT SPECIFIC IMPLANT PRESCRIPTION FORM WAS RECEIVED FOR PATIENT'S IMPENDING REVISION. WITH DIAGNOSIS "RE-BUSHINGS DFR FROM 1989" ADDITIONAL NOTES INDICATE: RE-BUSHINGS IN 2012, BUSHES REF: STBSH01-02, BME: 17262, CIRCLIP: REF SMCIC01.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    A PATIENT SPECIFIC IMPLANT PRESCRIPTION FORM WAS RECEIVED FOR PATIENT'S IMPENDING REVISION WITH DIAGNOSIS "RE-BUSHINGS DFR FROM 1989" ADDITIONAL NOTES INDICATE: RE-BUSHINGS IN 2012, BUSHES REF: STBSH01-02, BME: 17262, CIRCLIP: REF SMCIC01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285106 DISTAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE PIN 3541

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R DISTAL FEMUR PIN 1407| REBUSHING DISTAL FEMUR PIN 17262| SMCIC01 (B9619) CIRCLIP| STBSH01-02 (B9767) BUSHES