BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 56

    MDR report key: 7999373 · Received October 24, 2018

    Report

    Report Number
    3005180920-2018-00817
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807916
    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 23 OCTOBER 2018: LOT 160064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-21. 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. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER ON 23-OCT-2018: THE ACETABULAR CUP HAS SIGNS OF OSTEOINTEGRATION (RESIDUAL BONE) DEFORMATION AND SCRATCHES ON THE EDGE DUE TO REVISION PROCEDURE; THE FEMORAL HEAD HAS FEW TINY METAL TRANSFER SCRATCHES, AND SLIGHT STEM TAPER FOOTPRINT INSIDE THE TAPER CAVITY; THE ACETABULAR CERAMIC LINER HAS STEM IMPINGEMENT SIGN. THE REVISION IS DUE EXCESSIVE DIMENSION OF THE SHELL THAT WAS CAUSING PAIN, AS STATED BY THE SURGEON. HENCE, THE REVISION CAUSE IT IS NOT DEVICE RELATED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON OCT 24, 2018: ACETABULAR COMPONENT REVISION OCCURRED 2 YEARS AFTER IMPLANTATION DUE TO PAIN. ACCORDING TO THE REPORT, THE CAUSE OF PAIN WAS AN OVERSIZED SHELL. PREOPERATIVE X-RAYS ARE NOT AVAILABLE. NO CONCLUSION ON THE REASON OF CHOICE OF A LARGE IMPLANT SIZE CAN BE DRAWN.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP BECAUSE THE CUP IMPLANTED IN PRIMARY SURGERY WAS TOO BIG. THE SIZE 56 CUP WAS REPLACED WITH A SIZE 52; THE LINER AND THE HEAD WERE SWAPPED, TOO. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839546 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 56 HIP CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 160064 07630030807916

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention