BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 46

    MDR report key: 10800548 · Received November 6, 2020

    Report

    Report Number
    3005180920-2020-00779
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    October 30, 2020
    Report Date
    December 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807749
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED ON (B)(6) 2020. FROM THE RECEIVED PHOTOS, NO PARTICULAR OR EVIDENT SIGNS ARE PRESENT IN THE COMPONENTS, SO THERE ARE NO PARTICULAR SUSPECTS FOR A FAILURE DEVICE. ACCORDING TO WHAT STATED IN THE CLINICAL EVALUATION, A POSSIBLE CAUSE CAN BE RELATED TO THE SURGERY AND POSITIONING OF THE IMPLANT, BUT THERE IS NO CERTAINTY ON THIS.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 182552: 140 ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2018. EXPIRATION DATE: 2023-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 126 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION. TWO YEARS AFTER PRIMARY CEMENTLESS THA THE CUP IS PAINFUL AND FOUND TO BE LOOSE. A CRANIAL CAVITY IS PRESENT AT THE IMPLANT-BONE INTERFACE. THE CUP WAS POSSIBLY A LITTLE TOO LATERAL, FOR UNSPECIFIED REASONS IT MAY NOT HAVE BEEN POSSIBLE TO PLACE IT AT THE BOTTOM OF THE ACETABULAR CAVITY WITH A COMPLETE REAMING OF THE SUPERIOR COLUMN. NO REASON TO THINK THAT THIS REVISION WAS CAUSED BY A DEFECTIVE IMPLANT.

    Description of Event or Problem · 1

    ASEPTIC CUP MOBILIZATION. THE SURGEON REVISED CUP, LINER AND HEAD 1 YEAR AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269302 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL 46 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0046 182552 07630030807749

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention