BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C

    MDR report key: 10136934 · Received June 10, 2020

    Report

    Report Number
    3005180920-2020-00317
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 13, 2020
    Report Date
    July 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807091
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 16TH OF JUNE 2020 THE EXTERNAL SUPPLIER PERFORMED THE BATCH REVIEW OF THE ITEM REFERENCE 38.49.7175.455.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 LOT. 7011108288 (ITEM NOT REGISTERED IN USA). THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 25 MAY 2020: LOT 165409: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2016. EXPIRATION DATE: 2021-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 25 MAY 2020: CUP: VERSAFITCUP CC TRIO 01.26.45.1148 ACETABULAR SHELL CC TRIO NO-HOLE 48 (K122911) LOT. 166745. LOT 166745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2017. EXPIRATION DATE: 2022-01-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT. STEM: QUADRA-C 01.12.042 CEMENTED, MIRROR POLISHING STD STEM SIZE 2 12/14 (K083558) LOT. 168424 LOT 168424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2017. EXPIRATION DATE: 2022-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT. IMPLANTS FROM CERAMTEC 38.49.7175.455.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M 0 LOT. 7011108288 (ITEM NOT REGISTERED IN USA, WE HAVE ASKED THE BATCH REVIEW TO THE EXTERNAL SUPPLIER).

    Description of Event or Problem · 1

    THE SURGEON DISCOVERED AN INFECTION 3 YEARS AFTER THE PRIMARY SURGERY (THE PATHOGEN IS UNKNOWN) AND DECIDED TO REMOVE ALL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602054 LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C FLAT PE HC LINER LZO MEDACTA INTERNATIONAL SA 01.26.2839HCT 165409 07630030807091

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention