BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 2870005 · Received December 7, 2012

    Report

    Report Number
    3005180920-2012-00086
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDACTA WAS INFORMED OF THE EVENT BY (B)(6), THE (B)(6) NATIONAL COMPETENT AUTHORITY, THAT WAS INFORMED BY THE SURGEON WHO PERFORMED THE REVISION SURGERY. (B)(4). SEEING THAT A BIOLOX OPTION HEAD WAS IMPLANTED AND THAT THIS KIND OF PRODUCT IS A REVISION BALL HEAD, MEDACTA HAS INVESTIGATED THE SITUATION WITH THE FOLLOWING RESULTS: THE PT WAS ALREADY REVISED ONCE ON (B)(6) 2011 DUE TO INSTABILITY OF THE HIP IMPLANT (WE WERE NOT INFORMED ABOUT THIS REVISION, WHEN IT WAS PERFORMED). A SUBSIDENCE OF THE STEM OCCURRED: THE SURGEON EVALUATED THE SITUATION AND FOUND THAT THE STEM WAS STABLE, BUT A LITTLE BIT SUBSIDED, SO HE DECIDED TO REPLACE THE HEAD ONLY, PASSING FROM A BIOLOX DELTA BALL HEAD 36 S TO A BIOLOX OPTION HEAD 36 XL TO RESTORE THE ORIGINAL LEG LENGTH. WE SUSPECT THAT, DURING THIS FIRST REVISION, SOMETHING HAPPENED AND THE NECK WAS SOMEHOW DAMAGED. THIS KIND OF PROBLEM COULD BE THE CAUSE OF THE BREAKAGE OCCURRED 22 MONTHS AFTER THIS REVISION. THE STEM IS AT AN INDEPENDENT LAB FOR ANALYSIS: THE SURGEON DIRECTLY SENT IT TO THE LAB. QUADRA H 12/14 CEMENTLESS STEMS ARE ON THE MARKET FOR MANY YEARS. (B)(4). MEDACTA RECEIVED A SIMILAR CASE ON A DIFFERENT FAMILY OF PRODUCT: QUADRA H 10/12 CEMENTLESS STEMS ((B)(4)), BUT WITH DIFFERENT NECK MEASURES (10/12 INSTEAD OF 12/14). THIS VERSION OF QUADRA WAS THE FIRST VERSION MADE BY MEDACTA ONLY FOR SOME YEARS IN THE EARLY 2000, PASSING THEN TO THE 12/14 STANDARD CONE. ONLY THE 12/14 VERSION IS CLEARED IN THE USA. THIS CASE OCCURRED IN (B)(6) AND WAS REPORTED TO THE (B)(6) COMPETENT AUTHORITY ON (B)(6) 2011: THE FIRST IMPLANTATION WAS IN 2002 AND, ALSO IN THE CASE, THERE WAS A CERAMIC HEAD REVISION, DONE IN 2007. WE REQUESTED THE ANALYSIS ON THE BROKEN STEM BY AN EXTERNAL LABORATORY AND, FROM THE FINAL REPORT, IT RESULTED THAT THE ENTIRE NECK PRESENTS DAMAGES ON THE SURFACE AND SCRATCHES WITH A STRIKING VARIATION OF ITS PROFILE. THESE DAMAGES ARE HIGHLY LIKELY CONNECTED TO THE CERAMIC HEAD SUBSTITUTION THAT OCCURRED IN THE 2007. ALSO THE TOP OF THE STEM WAS HIGHLY DAMAGED, FOR THE SAME REASON DESCRIBED ABOVE. THEY CONCLUDED THAT THE BREAKAGE OF THE DEVICE WAS NOT DUE TO METALLURGICAL PROBLEMS OF THE STEM. MOST PROBABLY, THE BREAKAGE COULD BE CAUSED BY TWO POSSIBLE FACTORS: PRESENCE OF ANOMALOUS LOADS DUE TO THE DAMAGES TO THE TOP OF THE STEM THAT COULD HAVE CAUSED A PARTIAL CONTACT BETWEEN THE STEM AND THE NECK AND A DEFORMATION OF THE NECK WITH UNEXPECTED FLEXURAL LOADS AND TRACTIONAL OVERSTRESSES WHERE THE BREAKAGE STARTED. PRESENCE OF SCRATCHES AND DAMAGES ON THE NECK THAT ACT AS STRESS RISERS REDUCING THE FATIGUE LIMIT OF THE DEVICE. WE THINK THAT THE PROBLEM OCCURRED IS HIGHLY LIKELY NOT DEVICE RELATED, BUT DUE TO DAMAGES DURING THE FIRST REVISION SURGERY. WE ARE WAITING FOR THE ANALYSIS OF THE EXTERNAL LABORATORY: THEY HAVE ALREADY FORESEEN THE EMISSION OF THE FINAL REPORT BY THE END OF (B)(4) 2013, SPECIFYING THAT THREE MONTHS ARE THE STANDARD FOR A SIMILAR ANALYSIS. A FOLLOW UP WILL BE SUBMITTED ONCE WE RECEIVE THIS REPORT.

    Description of Event or Problem · 1

    SPONTANEOUS NECK FRACTURE OF THE FEMORAL STEM, GETTING OUT OF A CAR. ALL COMPONENTS HAVE BEEN REVISED. WE WERE INFORMED ON (B)(6) 2012 ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 4 LAT CEMENTLESS JDI MEDACTA INTERNATIONAL SA 090016

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention CERAMIC BALL HEAD| ACETABULAR CUP NOT MARKETED IN USA| CERAMIC LINER