BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0 LOT. 102677

    MDR report key: 7463814 · Received April 26, 2018

    Report

    Report Number
    3005180920-2018-00274
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 26, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802010
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 APRIL 2018. LOT 102677: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2010. EXPIRATION DATE: 2015-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER IMPLANT INVOLVED IS VERSAFITCUP CC TRIO 01.26.45.0048 (K103352) ACETABULAR SHELL CC TRIO Ø 48. LOT 130558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 APRIL 2013. EXPIRATION DATE: 2018-02-28 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. CLINICAL EVALUATION PERFORMED ON 25 APRIL 2018 BY MEDICAL AFFAIRS DIRECTOR: FIVE YEARS AFTER PRIMARY CEMENTLESS THA A TOTAL REVISION IS REQUIRED. THE STEM IS MOBILIZED AND THE CUP NEEDS REPOSITIONING. THE STEM LOOKS UNDERSIZED AND CUP INCLINATION SUBOPTIMAL. THE POSTOPERATIVE HISTORY IS NOT KNOWN. WE MAY SUPPOSE THAT UNDERSIZED AND POSITIONING MAY HAVE PLAYED A ROLE IN THE SETTING OF THE EVENT, BUT WE MUST ALSO CONSIDER THAT THE DEVICES REMAINED IN SITU FOR 5 YEARS. THE CONCLUSION ON THE CAUSES OF THE INCIDENT CAN THEREFORE NOT BE FINAL, BUT THERE IS NO APPARENT REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2018 MEDACTA'S CUSTOMER SERVICE HAS BEEN INFORMED ABOUT A REVISION HIP SURGERY, REASON FOR REVISION UNKNOWN. REVISION SURGERY BOOKED (B)(6) 2018. POST REVISION INFORMATION RECEIVED BY MAIL BY SALES REPRESENTATIVE ON THE (B)(4) 2018: THE PATIENT COMPLAINED LONG TERM PAIN. DIAGNOSIS FROM SURGEON IS ASEPTIC LOOSENING OF FEMORAL COMPONENT. ACETABULAR MALPOSITIONING. ANTERIOR WALL DEFICIT. REVISION WAS COMPLETED (B)(6) 2018. STEM GROSSLY LOOSE, REMOVED BY HAND WITH BURNISHING OF DISTAL TIP. ACETABULAR COMPONENT REMOVED . CUP POSITIONED WITH ANTERIOR WALL DEFECT AT INDEX SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308310 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0 LOT. 102677 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 102677 07630030802010

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention