BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

    MDR report key: 10167002 · Received June 18, 2020

    Report

    Report Number
    3005180920-2020-00339
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802058
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JUNE 2020: LOT 145664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2014. EXPIRATION DATE: 2019-09-30. 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 SINCE 2016. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED BY REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: CUP: VERSAFITCUP CC TRIO 01.26.45.1154 ACETABULAR SHELL CC TRIO NO-HOLE 54 (K122911) LOT. 143350. LOT 143350: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2014. EXPIRATION DATE: 2019-06-30. 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 SINCE 2016. LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE HC LINER 32 / E (K103352) LOT. 144768. LOT 144768: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. IMPLANTS FROM CERAMTEC 38.49.7175.685.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L +4 LOT. 7010866337 (ITEM NOT REGISTERED IN USA). THE QUALITY DOCUMENTS (INCLUDING THE STERILIZATION CERTIFICATES) SHOW THAT THE VALUES OBTAINED IN THE BALL HEAD WERE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFILL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION.

    Description of Event or Problem · 1

    THE PATIENT HAS PAIN ON THE FEMUR SIDE AND THE SPECT-CT SHOWS RED COLOURS ON THE FEMORAL STEM. THE PATIENT HAS AN ALLERGY OF TITANIUM, REASON WHY THE SURGEON MUST REVISE THE ALL PROSTHESIS. SAMPLES TAKEN DURING THE REVISION SURGERY SHOWED AN INFECTION. THE REVISION SURGERY WAS SUCCESSFULLY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634416 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4 CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.024 145664 07630030802058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention