BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE Ø 50

    MDR report key: 8649829 · Received May 29, 2019

    Report

    Report Number
    3005180920-2019-00427
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807886
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 MAY 2019: LOT 172698: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2017. EXPIRATION DATE: 2022-09-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BATCH REVIEW PERFORMED BY THE CERAMIC LINER MANUFACTURER CERAMTEC: IMPLANTS FROM CERAMTEC 38.49.7188.545.20 CERAMIC LINER Ø 36 / E LOT. 7011143368 (NOT REGISTERED IN US): DUE TO LACK OF INFORMATION ABOUT THE LASER ENGRAVING, THE IDENTIFICATION OF THE INSERT IS ONLY POSSIBLE BASED ON THE INFORMATION PROVIDED BY MEDACTA. THE INSERT BELONGS TO THE SHOP ORDER (B)(4). PROTOCOLS AND CERTIFICATE OF CONFORMANCE WERE REVIEWED. THE QUALITY DOCUMENTS (INCLUDING THE STERILIZATION CERTIFICATES) SHOW THAT THE VALUES OBTAINED ON THE INSERT WERE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF THE PRODUCTION. CONCLUSIONS: THE COMPONENT PROPERTIES AND THE 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 DEFECTS OR NON-CONFORMANCES REGARDING STERILIZATION. DUE TO THE LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT LATE INFECTION IN CEMENTLESS THA, 1.5 YEARS 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 1,5 YEARS FROM THE PRIMARY DUE TO A SEPTIC INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY: ABLATION OF THE ACETABULUM AND THE LINER. THE SURGEON COULDN'T REMOVE THE STEM (DESPITE THE USING OF THE EXTRACTOR) HE DECIDED TO LEAVE IT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442228 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL NO-HOLE Ø 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 172698 07630030807886

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention