BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD

    MDR report key: 5666917 · Received May 19, 2016

    Report

    Report Number
    3005180920-2016-00230
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    May 28, 2014
    Report Date
    July 25, 2016
    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

    ON 22 JULY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION BASED ON THE X-RAYS RECEIVED ON 27 JUNE 2016, AND COMMENTED AS FOLLOWS: CEMENTLESS THA REVISED AFTER 6 YEARS FOR EVIDENT FEMORAL OSTEOLYSIS. LIKELY DUE TO REACTION TO WEAR DEBRIS OF THE PE INSERT, AS VISIBLE ON THE X-RAY. THE PATIENT AT THE TIME OF PRIMARY OPERATION WAS A MALE OF (B)(6). ALL COMPONENTS WERE PLACED CORRECTLY, BUT THE CHOICE OF STANDARD POLYETHYLENE FOR SUCH A PATIENT, WITH MONOLATERAL PRIMARY COXARTHROSIS, IS RATHER UNWISE, AND THIS WAS WELL KNOWN IN THE ORTHOPEDIC COMMUNITY IN 2009.

    Additional Manufacturer Narrative · 1

    ON 18 MAY 2016 MEDACTA INTERNATIONAL REQUESTED A BATCH REVIEW OF THE CERAMIC BALL HEAD INVOLVED IN THIS COMPLAINT AND MANUFACTURED BY (B)(4). BATCH REVIEWS PERFORMED ON 19 MAY 2016. LOT 091034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JUNE 2009. EXPIRATION DATE: 2014-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP FLAT PE LINER Ø 28/E, CODE 01.26.2844STT, LOT. 060220 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 APRIL 2006. EXPIRATION DATE: 2011-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON AN ITEM OF THE SAME LOT (MDR 2016-0231). VERSAFITCUP METAL BACK CC LIGHT Ø 54, CODE 01.26.54MBTL, LOT. 091579 (NOT MARKETED IN USA) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 AUGUST 2009. EXPIRATION DATE: 2014-06-30. 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 Manufacturer Narrative · 1

    ON 27 MAY 2016 (B)(4) PROVIDED THE DOCUMENT REVIEW OF THE PRODUCT INVOLVED IN THIS COMPLAINT (CERAMIC BALL HEAD, NOT MARKETED IN USA) AND COMMENTED AS FOLLOWS:THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION.DUE TO THE LACK OF CERAMIC PARTS, NO FURTHER INVESTIGATION COULD BE DONE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE PATIENT INFORMED THE SURGEON DURING THE CLINIC VISIT ABOUT THE INCREASING PAIN IN THE LEFT HIP. ON (B)(6) 2015 THE REVISION SURGERY TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322972 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 091034

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention