BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 STD

    MDR report key: 5666922 · Received May 19, 2016

    Report

    Report Number
    3005180920-2016-00231
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    March 25, 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: MALE PATIENT OF (B)(6) AT THE TIME OF PRIMARY CEMENTLESS THA (2009). COMPONENTS CORRECTLY IMPLANTED AND WELL-FUNCTIONING. AFTER 6+ YEARS, PROBLEMS AT FIXATION OF FEMORAL STEM, APPARENTLY DUE TO OSTEOLYTIC REGIONS. THE INTRAOPERATIVE FINDING AT REVISION WAS RATHER PECULIAR, BUT NO INFECTION HAS BEEN PROVEN. IT IS POSSIBLE THAT THE REACTION WAS INDUCED BY PE WEAR DEBRIS. A MALE PATIENT OF (B)(6) WITH MONOLATERAL COXARTHROSIS SHOULD NOT HAVE BEEN GIVEN A STANDARD PE INLAY IN 2009.

    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.

    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 091437: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 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. VERSAFITCUP ACETABULAR SHELL CC LIGHT Ø 54, CODE 01.26.54MBTL, LOT. 083710 (NOT MARKETED IN USA). THE (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 FEBRUARY 2009. EXPIRATION DATE: 2013-12-31. 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. VERSAFITCUP FLAT PE LINER Ø 28 / E, CODE 01.26.2844STT, LOT. 060220 (K103352). THE (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 2016-0230).

    Description of Event or Problem · 1

    THREE YEARS AFTER THE PRIMARY SURGERY AND DURING THE CLINIC VISIT THE PATIENT INFORMED THE SURGEON ABOUT THE INCREASING PAIN IN THE RIGHT HIP. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320409 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 4 STD FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 091437

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention