BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

    MDR report key: 11633015 · Received April 8, 2021

    Report

    Report Number
    3005180920-2021-00279
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807770
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17.MAR.2021: LOT 174453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-NOV-2017. EXPIRATION DATE: 2022-10-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: MINIMAX 01.13.103R CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3 (K170845) LOT. 1810275. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17.MAR.2021: LOT 1810275: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2019. EXPIRATION DATE: 2024-03-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: AFTER THREE YEARS, THE PATIENT OF THIS CEMENTLESS THA SUFFERS PAIN, WHICH IS PROBABLY CAUSED BY THE PROGRESSION OF HIS LUMBAR LORDOSIS WHICH LEADS TO IMPINGEMENT BETWEEN STEM NECK AND POSTERIOR EDGE OF THE CUP. THE CUP IS EXCHANGED AND REPOSITIONED. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN AND DURING THE REVISION SURGERY, WHICH WAS PERFORMED 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, STEM NECK-CUP IMPINGEMENT AND METALLOSIS WERE NOTICED. THE SURGEON BELIEVES THAT A COMBINATION OF THE PATIENT LUMBAR LORDOTIC ANGLE AND THE FIRST REVISION SURGERY((B)(6) 2020 THIS PATIENT HAD A STEM AND HEAD REVISION DUE TO STEM MOBILIZATION) TO A MINIMAX STEM WITH INBUILT ANTEVERSION, MAY HAVE RESULTED IN THE POSTERIOR IMPINGEMENT (BETWEEN THE CUP AND THE NECK OF THE STEM), AND SUBSEQUENT REQUIREMENT FOR LESS ANTEVERSION ON THE CUP. THE SURGEON REVISED THE CUP, LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536068 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52 CEMENTLESS ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 01.26.45.0052 174453 07630030807770

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention