BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 12 HOLE / L274MM

    MDR report key: 6258443 · Received January 17, 2017

    Report

    Report Number
    0008031020-2017-00033
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 20, 2016
    Report Date
    July 17, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    UDI-DI
    07613252579670
    PMA / PMN Number
    K123964
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 12 HOLE / L274MM WAS ALLEGED OF 'IMPLANT BREAKAGE AFTER SURGERY' COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE PATIENT RELATED. THE FAILURE WAS CAUSED BY FATIGUE/OVERLOAD. THE DEVICE INSPECTION REVEALED THE BREAKAGE SURFACE OF THE PLATE IS CONSISTENT WITH A FATIGUE BREAKAGE. THIS OCCURS WHEN THE DEVICE IS SUBJECTED TO A HIGH LOAD DURING A CERTAIN PERIOD OF TIME. AN OVERLOADING OF THE PLATE WOULD THEN CAUSE THE BREAKAGE OBSERVED. MOREOVER, IT WAS REPORTED THAT THE PATIENT HAD NON-UNION OF BONE (NO CONSOLIDATION AFTER 5 MONTHS) AND THE PATIENT WAS (B)(6), THEREFORE HER BONE QUALITY MIGHT NOT BE OPTIMAL (OSTEOPOROSIS, SLOW OSTEOSYNTHESIS). IN ADDITION, HER PERSONAL CHARACTERISTICS POINT TO A WEIGHT OVER THE AVERAGE (B)(6), WHICH ARE FACTORS THAT CONTRIBUTE TO OVERLOADING OF THE PLATE AND ARE CLEARLY DESCRIBED IN THE INSTRUCTIONS FOR USE AS ADVERSE EFFECTS AND CONTRAINDICATIONS OF THIS DEVICE. NOTE, AS STATED IN THE IFU (V15013): ¿3 CONTRAINDICATIONS. THE PHYSICIAN¿S EDUCATION, TRAINING AND PROFESSIONAL JUDGEMENT MUST BE RELIED UPON TO CHOOSE THE MOST APPROPRIATE DEVICE AND TREATMENT. CONDITIONS PRESENTING AN INCREASED RISK OF FAILURE INCLUDE: ¿ OBESITY. AN OVERWEIGHT OR OBESE PATIENT CAN PRODUCE LOADS ON THE IMPLANT THAT CAN LEAD TO FAILURE OF THE FIXATION OF THE DEVICE OR TO FAILURE OF THE DEVICE ITSELF. [¿] 6 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, OSTEOMALICIA, 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.¿ [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

    REP REPORTED SCHEDULED REVISION SURGERY FOR A BROKEN LEFT LATERAL FEMURAL PLATE ON (B)(6) 2016 DUE TO THE PLATE BREAKING.

    Description of Event or Problem · 1

    REP REPORTED SCHEDULED REVISION SURGERY FOR A BROKEN LEFT LATERAL FEMORAL PLATE ON (B)(6) 2016 DUE TO THE PLATE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40628 DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR LEFT FEMUR 12 HOLE / L274MM PLATE, FIXATION, BONE HRS STRYKER GMBH 627642 V03504 07613252579670

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention