BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5

    MDR report key: 10313460 · Received July 23, 2020

    Report

    Report Number
    3005180920-2020-00449
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802171
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA HIP R&D MANAGER: THE FEMORAL STEM IS FRACTURED IN 2 PIECES IN THE NECK PORTION: THE PROXIMAL PART IS STILL CONNECTED TO THE CERAMIC FEMORAL HEAD, THROUGH A METALLIC SLEEVE. THE CERAMIC FEMORAL HEAD HAS MANY SCRATCHES AND GRAY SIGNS PROBABLY DUE TO THE RUBBING AGAINST METAL SURFACES, SUCH AS THE FRACTURED NECK OF THE FEMORAL STEM. THE PROXIMAL PART OF THE NECK HAS SOME SCRATCHES AND 3 DEEPER INDENTATIONS CLOSED TO THE FRACTURE. THE FRACTURED SURFACE IS NOT POLISHED BUT ROUGH. THE DISTAL PORTION OF THE DISTAL PART SHOWS BONE RESIDUAL; ON THE FRACTURED NECK, MANY SCRATCHES, FEW BURNS AND 2 DEEPER INDENTATIONS ARE NOTED. THE 2 INDENTATIONS ARE CLOSED TO THE FRACTURE AND CORRESPONDING TO THE POSITION OF THE 3 INDENTATIONS NOTED IN THE PROXIMAL PART OF THE NECK. THESE DEEP SCRATCHES (SURFACE INDENTATION) WERE PRESENT ON THE NECK BEFORE THE BREAKAGE OCCURRED. THE FRACTURED SURFACE IS POLISHED, ALD ALSO ITS EDGE, PROBABLY DUE TO THE RUBBING AGAINST THE CERAMIC HEAD. THE ROOT CAUSE OF THE EVENT IS LIKELY THE SURFACE CRACKS THAT WITH TIME MAY LEAD TO FRACTURE OF THE INVOLVED REGION; THE CRACKS ARE CAUSED BY SOME BURNS DUE TO THE ELECTRO-CUTTER OR BY SOME SCRATCHES DUE TO THE MULTIPLE REVISION SURGERIES.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14-JUL-2020: LOT 161560: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUNE-2016. EXPIRATION DATE: 05-MAY-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED LINER: VERSAFITCUP CC TRIO 01.26.3648HCT FLAT PE HC LINER 36 / F (K103352) LOT 162312: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2016. EXPIRATION DATE: 23-JUN-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. THE OTHER REVISED COMPONENTS ARE NOT MARKETED IN THE USA. PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D HIP MANAGER: FROM THE IMAGES RECEIVED NO CONCLUSIONS CAN BE ACHIEVED. WE WILL WAIT TO RECEIVE THE DEVICES IN ORDER TO DEEPLY ANALYSE THE EVENT.

    Description of Event or Problem · 1

    IMPLANT NECK BREAKAGE, PRIMARY SURGERY PERFORMED ON (B)(6) 2016. REVISION SURGERY PERFORMED ON (B)(6) 2020 (3 YEARS AND 6 MONTHS AFTER PRIMARY). THE PATIENT HAD MULTIPLE REVISION SURGERIES DUE TO INFECTION, IN 2017 AND 2019. IN THOSE REVISIONS SURGERIES, THE HEAD AND THE LINER WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782174 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5 HIP UNCEMENTED STEM JDI MEDACTA INTERNATIONAL SA 01.12.035 161560 07630030802171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S