BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO 01.26.3244STT FLAT PE LINER 32 / E

    MDR report key: 12352941 · Received August 23, 2021

    Report

    Report Number
    3005180920-2021-00663
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 21, 2021
    Report Date
    September 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807589
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDACTA R&D HIP PROJECT MANAGER COMMENTS AFTER DEVICE MEASUREMENTS: UPDATE OF 22ND SEPTEMBER 2021: MEASUREMENTS OF THE INNER SPHERE WERE TAKEN, BUT A COMPARISON WITH THE ORIGINAL PIECE WAS NOT POSSIBLE. RESPECT TO THE SPECIFICATIONS OF THE DRAWING, THE DIMENSION WAS SLIGHTLY INCREASED OF ABOUT 0.4MM ON THE DIAMETER. THIS INCREASE OF THE DIMENSION IS SMALL, AND IT'S PROBABLY DUE TO THE PRESENCE OF A THIRD BODY IN ARTICULATION, COMPATIBLE WITH THE SCRATCHES VISIBLE ON THE BEARING SURFACE . CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 4 YEARS AFTER PRIMARY CEMENTLESS THR, REVISION IS REQUIRED BECAUSE, ACCORDING TO THE REPORT, ABNORMAL WEAR OF THE PE INSERT HAS OCCURRED. THERE IS NO RADIOGRAPH AVAILABLE TO SHOW THE POSITION OF THE ORIGINAL HIP, SO WE CANNOT COMMENT ON THAT. THE POSSIBLE OSTEOLYTIC EFFECT OF THE WEAR PARTICLES IS NOT SHOWN EITHER, AND IT'S NOT MENTIONED IN THE REPORT. FROM THE IMAGES RECEIVED, IT APPEARS THAT THE BEARING SURFACE OF THE CUP IS SCRATCHED, WHICH IS COMPATIBLE WITH THE PRESENCE OF A THIRD BODY IN ARTICULATION, WHICH COULD ALSO EXPLAIN THE MACROSCOPIC WEAR AFTER ONLY 4 YEARS, WHICH CLEARLY INDICATES THAT SOMETHING ABNORMAL HAS HAPPENED. BECAUSE OF INSUFFICIENT INFORMATION, NO FINAL CONCLUSION CAN BE REACHED AT THIS STAGE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26.07.2021: LOT 170105: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-03-2017. EXPIRATION DATE: 2022-03-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D MANAGER: FROM THE RECEIVED PARTS IT WAS NOTICED SOME SIGNS ON THE POLY ON THE RIM, PROBABLY OCCURRED DURING THE REVISION SURGERY; ON THE INNER SURFACE, ALSO SURFACE DOES NOT APPEAR SMOOTH, PROBABLY DUE TO A THIRD BODY PRESENCE, BUT IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY. AS THE MATERIAL IS STANDARD PE, A POSSIBLE SLIGHT WEAR COULD BE OCCURRED; IN ORDER TO HAVE A BETTER IDEA ON THAT, QUALITY CONTROL MEASUREMENTS ON INNER SURFACE HAVE BEEN REQUIRED.

    Description of Event or Problem · 1

    3 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, CUP, HEAD AND LINER WERE REVISED DUE TO SUSPECTED LINER WEAR. THE SURGEON IMPLANTED SIZE 54 HEAD, REINFORCEMENT CAGE WITH 3 SCREWS AND APRICOT 48 CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250387 VERSAFITCUP CC TRIO 01.26.3244STT FLAT PE LINER 32 / E HIP LINER FLAT LZO MEDACTA INTERNATIONAL SA 01.26.3244STT 170105 07630030807589

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention