BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S CEMENTLESS STEM #2 STD SHORT NECK

    MDR report key: 4643420 · Received March 27, 2015

    Report

    Report Number
    3005180920-2015-00045
    Event Type
    Injury
    Date Received
    March 27, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE X-RAYS RECEIVED HAVE BEEN ANALYZED BY THE MEDICAL AFFAIRS ON (B)(6) 2015, WITH THE FOLLOWING COMMENT: XRAYS WERE THEN RECEIVED. THE FRACTURE THAT ORIGINATED THE PRIMARY IMPLANTATION EXTENDS DISTALLY AND LATERALLY ALMOST TO THE 4/5 OF THE STEM LENGTH. THEREFORE, A LONGER STEM COULD PROBABLY HAVE SUPPLIED A BETTER STABILITY AND ALLOWED FRACTURE HEALING. THE STEM IN THE RADIOGRAPH LOOKS SIGNIFICANTLY IN VARUS POSITION, WE DO NOT KNOW IF THIS WAS THE SITUATION POSTOPERATIVELY OR DUE TO SUBSEQUENT MOBILIZATION. THE ROOT CAUSE FOR THIS FAILURE IS IN MY OPINION THE CHOICE OF TOO SHORT A STEM FOR THIS EXTENDED FRACTURE CASE. IT WAS CERTAINLY A COMPLEX CASE WITH HIGH RISK OF SECONDARY COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    ON 04/03/2015 THE MEDICAL AFFAIRS MADE THE FOLLOWING COMMENT: LITTLE AND CONTRADICTORY INFORMATION IS AVAILABLE. APPARENTLY, A QUADRA STEM HAD BEEN IMPLANTED IN 2012 ON A FEMORAL FRACTURE AND EXPLANTED IN (B)(6) 2015 FOR MOBILIZATION, BUT NO INFORMATION ON X-RAY HAVE BEEN PROVIDED. BASED ON THE ABOVE, I CANNOT EXECUTE A CLINICAL ASSESSMENT. NO COMPLAINT HAS BEEN RECEIVED INDICATING A PROBLEM WITH THE IMPLANTS, TO MY KNOWLEDGE. ON 04/28/2015, A CD WITH X-RAYS IS RECEIVED AND WILL BE ANALYZED SOON. A NEW FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ON 07/08/2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT AND IN THE FIRST AND SECOND FOLLOW UPS. ON THE SAME DAY THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03/25/2015: LOT 120921: 20 STEMS PRODUCED AND RELEASED ON 03/15/2012. NO ANOMALIES FOUND. TO DATE, ALL THE STEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. ON 03/25/2015 WE WERE INFORMED THAT THE EXPLANTED STEM IS NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    REF IMP #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205010 QUADRA S CEMENTLESS STEM #2 STD SHORT NECK CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1