BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS, HA COATED STD STEM SIZE 7

    MDR report key: 10430567 · Received August 20, 2020

    Report

    Report Number
    3005180920-2020-00525
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 20, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802089
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 AUGUST 2020. LOT 180848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2018. EXPIRATION DATE: 2023-05-13. 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 DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 31 JULY 2020. CUP: VERSAFITCUP CC TRIO 01.26.45.0062 ACETABULAR SHELL CC TRIO 62 (K103352) LOT 144699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2014. EXPIRATION DATE: 2019-08-30. 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. BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION 36 (K131518) LOT 177731: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2018. EXPIRATION DATE: 2023-04-09. 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. BALL HEADS: MECTACER 01.29.242A SLEEVE SIZE L (K131518) LOT 176863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-GEN-2018. EXPIRATION DATE: 2023-01-02. 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. THE EXPLANTED LINER IS NOT MARKETED IN THE USA. CLINICAL EVALUATION PERFORMED BY MEDATA MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTLESS THA, 16 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY DUE TO CHRONIC INFECTION. THE SURGEON REVISED ALL PROSTHESIS. THE REVISION WAS SUCCESSFULLY COMPLETED VIA POSTERIOR APPROACH AND A CEMENT SPACER WAS INSERTED. THE PATHOGEN WAS STREPTOCOCCUS MITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896426 AMISTEM H CEMENTLESS, HA COATED STD STEM SIZE 7 HIP UNCEMENTED STEM JDI MEDACTA INTERNATIONAL SA 01.12.027 180848 07630030802089

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention