BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 10 HOLE / L238MM

    MDR report key: 6090860 · Received November 9, 2016

    Report

    Report Number
    0008031020-2016-00538
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 11, 2016
    Report Date
    January 27, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K123964
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 10 HOLE / L238MM WAS ALLEGED OF 'IMPLANT BREAKAGE AFTER SURGERY' COULD BE CONFIRMED, SINCE THE RETURNED DEVICE AS WELL AS THE MEDICAL RECORDS PROVIDED SUSTAIN THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE PATIENT RELATED. THE FAILURE WAS CAUSED BY OVERLOADING OF THE PLATE DUE TO A NON-UNION OF THE BONE. THE DEVICE INSPECTION REVEALED THAT THE PLATE IS BROKEN AND THAT THE SURFACE FRACTURE IS CONSISTENT WITH A FATIGUE BREAKAGE DUE TO OVERLOADING OF THE PLATE. A CLINICAL ASSESSMENT WAS DONE AND THE FOLLOWING CONCLUSION WAS REACHED: ¿THE GIVEN CASE PRESENTS A TYPICAL FATIGUE BREAKAGE OF AN INTERNAL FIXATION PLATE DUE TO LONG TERM OVERLOADING IN A NON-UNION WITH UNSTABLE FRAGMENT CONSTELLATION.¿ BOTH DEVICE INSPECTION AND CLINICAL ASSESSMENT ARE CONSISTENT AND POINT TO THE SAME CONCLUSION THAT THE NON-UNION OF THE BONE WAS THE CAUSE FOR THE OVERLOADING OF THE PLATE, AND CONSEQUENTLY ITS BREAKAGE. NOTE, AS STATED IN THE IFU (V15013): ¿ADVERSE EFFECTS: IN MANY INSTANCES, ADVERSE RESULTS MAY BE CLINICALLY RELATED RATHER THAN DEVICE RELATED. THE FOLLOWING ARE THE MOST FREQUENT ADVERSE EFFECTS INVOLVING THE USE OF INTERNAL FRACTURE FIXATION DEVICES: DELAYED UNION OR NON-UNION OF THE FRACTURE SITE. THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNIONS AND/OR NON-UNIONS. INTERNAL FIXATION DEVICES ARE LOAD SHARING DEVICES WHICH ARE INTENDED TO HOLD FRACTURED BONE SURFACES IN APPOSITION TO FACILITATE HEALING. IF HEALING IS DELAYED OR DOES NOT OCCUR, THE APPLIANCE MAY EVENTUALLY BREAK DUE TO METAL FATIGUE. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE DEVICE. CONDITIONS ATTRIBUTABLE TO NON-UNION, OSTEOPOROSIS, OSTEOMALACIA, DIABETES, INHIBITED REVASCULARIZATION AND POOR BONE FORMATION CAN CAUSE LOOSENING, BENDING, CRACKING, FRACTURE OF THE DEVICE OR PREMATURE LOSS OF RIGID FIXATION WITH THE BONE. IMPROPER ALIGNMENT CAN CAUSE A MAL-UNION OF THE BONE AND/OR BENDING, CRACKING OR EVEN BREAKAGE OF THE DEVICE.¿ [ORIGINAL STATEMENT(S)] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PLATE SHAFT WAS FOUND TO BE DAMAGED AFTER THE PROCEDURE. PERFORMED REVISION. PATIENT WAS REVISED WITH USING ANOTHER AXSOS TI AFTER REFRESHED THE FRACTURES PART.

    Description of Event or Problem · 1

    THE PLATE SHAFT WAS FOUND TO BE DAMAGED AFTER THE PROCEDURE. PERFORMED REVISION. PATIENT WAS REVISED WITH USING ANOTHER AXSOS TI AFTER REFRESHED THE FRACTURES PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740447 DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 10 HOLE / L238MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. HRS STRYKER GMBH F03135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention