BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 LAT

    MDR report key: 5999694 · Received October 5, 2016

    Report

    Report Number
    3005180920-2016-00510
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 5, 2016
    Report Date
    March 31, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. ON (B)(6) 2014 THE DOUBLE MOBILITY PRODUCT WAS REVISED DUE TO A DISLOCATION OCCURRED ON (B)(6) 2014, WHICH WAS REPOSITIONED CLOSED. BECAUSE OF THAT, THERE WAS AN CHANGE TO A DOUBLE MOBILITY PRODUCT (REVISION ON (B)(6) 2014). BATCH REVIEW PERFORMED ON 13 SEPTEMBER 2016. LOT 145679: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 OCTOBER 2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 19 SEPTEMBER 2016 AND INCLUDES: THE PATIENT HAS BEEN SUCCESSFULLY REVISED ON 13 SEPTEMBER 2016. ON 23 SEPTEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FRACTURED QUADRA STEM AFTER LESS THAN TWO YEARS. AN ANALYSIS OF THE EXPLANTS IS MANDATORY IN ORDER TO ASCERTAIN POSSIBLE CAUSES FOR THE FRACTURE. THIS PATIENT UNDERWENT A REOPERATION FEW WEEKS AFTER PRIMARY THA BECAUSE OF RECURRENT DISLOCATION, AND THE ARTICULATION WAS CHANGED TO A DOUBLE MOBILITY SOLUTION, BUT THE STEM WAS WELL FUNCTIONING AND THEREFORE LEFT IN PLACE. IN OUR EXPERIENCE, OFTEN DURING THIS KIND OF INTERVENTION A MINIMAL, UNVOLUNTARY DAMAGE CAN BE MADE TO THE NECK OF THE STEM, VERY DIFFICULT TO NOTICE, AND HAVE DETRIMENTAL EFFECTS ON FATIGUE PROPERTIES OF THE IMPLANTED DEVICE. WE DO NOT KNOW IF THIS IS WHAT HAPPENED IN THIS CASE: EXPLANT ANALYSIS IS NECESSARY IN ORDER TO SAY SO. NO DEFINITIVE POSITION CAN BE TAKEN TO DATE ON THIS MATTER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 07 OCTOBER 2016 AND INCLUDES: THE PATIENT DID NOT AGREE TO GIVE THE BROKEN STEM TO MEDACTA INTERNATIONAL SA. HE WILL ANALYZE IT BY HIMSELF, AFTER THAT HE MAY PROVIDE THE IMPLANT TO MEDACTA INTERNATIONAL SA.

    Additional Manufacturer Narrative · 1

    ON 15 FEBRUARY 2017 THE RETRIEVED EXPLANTS WERE SENT TO AN EXTERNAL LABORATORY FOR FURTHER INVESTIGATIONS. NOT YET ANALYZED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 19 DECEMBER 2016 AND INCLUDES:THE PATIENT GAVE MEDACTA THE CONSENT TO SEND THE EXPLANTS TO AN EXTERNAL LAB FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ON 01 MARCH 2017, THE EXTERNAL LABORATORY PROVIDED THE INVESTIGATION REPORT, WITH THE FOLLOWING CONCLUSIONS: THE PERFORMED ANALYSIS ON THE FEMORAL STEM OF A HIP PROSTHESIS ALLOW TO STATE THAT THE FAILURE OF THE STEM OCCURRED BY MONO DIRECTIONAL BENDING MECHANICAL FATIGUE. THE MECHANICAL FATIGUE FAILURE WAS TRIGGERED BY THE PRESENCE OF THE ALTERATIONS ON THE NECK SURFACE OF THE STEM, IN PARTICULAR BY THE MELTED DOTS. THESE OBSERVED ANOMALIES REPRESENT THE STRESS RISER, THAT ORIGINATES A DISCONTINUITY ABLE TO PROPAGATE UNDER LOAD WITH A FATIGUE MECHANISM. AWAY FROM THE ANOMALIES ABOVE DESCRIBED, THE MICROSTRUCTURE OF THE STEM IS CONSTITUTED BY BANDED ALPHA+BETA GRAINS, CONGRUENT WITH THE DECLARED ALLOY TI-6AL-7NB. NO METALLURGICAL ANOMALIES OR DEFECTS REGARDING THE PRODUCTION PHASES OF THE STEM WERE DETECTED AND ARE THEREFORE TO BE EXCLUDED AS THE CAUSE OF THE FAILURE THAT TOOK PLACE. THE DETECTED ALTERATIONS ARE CLEARLY LINKED TO THE INTERACTION OF A HIGH-DENSITY POWER SOURCE (I.E. ELECTROSURGICAL KNIFE) WITH THE STEM. THE MEDACTA R&D PROJECT MANAGER INSPECTED THE RETRIEVED IMPLANT AND COMMENTED AS FOLLOWS: THE LABORATORY CONFIRMED OUR CONCLUSIONS. THE MECHANICAL FATIGUE FAILURE WAS TRIGGERED BY THE PRESENCE OF THE ALTERATIONS ON THE NECK SURFACE OF THE STEM, IN PARTICULAR BY THE MELTED DOTS. THE DETECTED ALTERATIONS ARE CLEARLY LINKED TO THE INTERACTION OF A HIGH-DENSITY POWER SOURCE (I.E. ELECTROSURGICAL KNIFE) WITH THE STEM. THE EVENT IS NOT IMPLANT RELATED.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED DUE TO BREAKAGE OF QUADRA STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650692 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 145679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention