BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

    MDR report key: 9525226 · Received December 27, 2019

    Report

    Report Number
    3005180920-2019-01084
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    November 30, 2019
    Report Date
    December 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808036
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 4 DECEMBER 2019. LOT 165684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2017 EXPIRATION DATE: 01/10/2022. 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 EVENTS. ADDITIONAL IMPLANT INVOLVED: STEM: MINIMAX 01.13.102R CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2 (K170845) LOT. 172015. BATCH REVIEW PERFORMED ON 4 DECEMBER 2019 LOT 172015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2017 EXPIRATION DATE: 18/08/2022. 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 EVENTS. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER HIP REVISION SURGERY PERFORMED 1 YEAR AND 8 MONTHS AFTER CEMENTLESS DOUBLE MOBILITY TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. RADIOGRAPHIC IMAGE PROVIDED SHOWS SUBOPTIMAL CUP POSITION. THE REASON OF THIS CHOICE IS UNKNOWN: BONE MORPHOLOGY OR PATIENT ANATOMY MAY BE ONE REASON BUT THIS CANNOT BE CONFIRMED ON THE BASIS OF A SINGLE ANTEROPOSTERIOR X-RAY. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY DUE TO IMPINGEMENT (THE CUP WITH THE STEM OR THE LESSER TROCHANTER WITH THE PELVIS). THE CUP WAS ANTEVERTED (THE CAUSE IS UNKNOWN). THE SURGEON REVISED THE HEAD AND LINER. INFECTION NOT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318799 CUP: VERSAFITCUP ACETABULAR SHELL Ø 48 ACETABULAR CUP MEH MEDACTA INTERNATIONAL SA 165684 07630030808036

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention