BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP, ACETABULAR SHELL CC TRIO NO-HOLE Ø 52

    MDR report key: 5406933 · Received February 3, 2016

    Report

    Report Number
    3005180920-2016-00015
    Event Type
    Injury
    Date Received
    February 3, 2016
    Date of Event
    January 4, 2016
    Report Date
    April 29, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 05 APRIL 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 19 JANUARY 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: MARKED RADIOGRAPHICAL MOBILIZATION SIGNS IN A THA 1,5 YEARS AFTER IMPLANTATION. THERE IS RADIOGRAPHICAL EVIDENCE OF DISTAL LOAD TRANSFER AND DISTAL PEDESTAL, BUT AS NO POST-OPERATIVE X-RAY IS AVAILABLE THE EARLY HISTORY CANNOT BE USED AS COMPARISON. REPORT DESCRIBES A SUSPECTED INFECTION, WHICH IS COMPATIBLE WITH THE IMAGES. A SPACER WAS IMPLANTED. IT SHOULD BE SURMISED THAT THE ROOT CAUSE FOR REVISION WAS INFECTION. ON 19 JANUARY 2016, CERAMTEC PROVIDED A DOCUMENT REVIEW OF THE INVOLVED LOTS MANUFACTURED BY THEM AND NOT MARKETED IN THE USA (CERAMIC HEAD AND CERAMIC LINER): THE COMPONENT PROPERTIES AND THE MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS OF BOTH PARTS ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF THE PRODUCTION. THERE ARE NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT OR NON CONFORMITIES REGARDING THE STERILIZATION. DUE TO LACK OF CERAMIC PARTS FURTHER INVESTIGATION CAN NOT BE DONE. BATCH REVIEW PERFORMED ON (B)(6) 2016 ON MEDACTA COMPONENTS: LOT 142421: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2014. EXPIRATION DATE: 2019-05-31. 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. AMISTEM H, HA COATED STEM SIZE 3 LAT, CODE 01.18.143, LOT. 132643 ((B)(4)); (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2013. EXPIRATION DATE: 2018-06-30. 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. ON 3RD FEB 2016 IT WAS COMMUNICATED THAT THE PATHOGEN WAS STAPHYLOCOCCUS EPIDERMIDIS. ON 3RD FEB 2016 THE R&D PROJECT MANAGER COMMENTED AS FOLLOWING WHILE CHECKING THE PICTURES OF THE EXPLANTS: OBSERVING THE IMAGES OF THE IMPLANTS NO PARTICULAR SIGN CAN BE NOTED. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMAGES DETERMINE THE ROOT CAUSE OF THE EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    REVISION FOR PAIN, THE PATIENT CAN NOT SET HIS FOOT. SUSPICION OF INFECTION. IMPLANTS WILL NOT BE AVAILABLE. CEMENT SPACER PUT IN PLACE AND IMPLEMENTATION WILL BE PERFORMED IN A SECOND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64992 VERSAFITCUP, ACETABULAR SHELL CC TRIO NO-HOLE Ø 52 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 142421

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention