BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

    MDR report key: 12950769 · Received December 7, 2021

    Report

    Report Number
    3005180920-2021-00952
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 9, 2021
    Report Date
    December 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807886
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18.11.2021: LOT 135286: (B)(4). EXPIRATION DATE: 2018-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: HIP REVISION SURGERY PERFORMED 7 YEARS AND 8 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) MAN. ACCORDING TO THE REPORT, THE CAUSE OF IMPLANT MOBILIZATION IS THE PRESENCE OF A GRANULOMA. RADIOGRAPHIC IMAGES PROVIDED SHOW BONE ALTERATIONS CONSISTENT WITH THE PRESENCE OF A MASS. THE CAUSE OF GRANULOMA IS UNKNOWN. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 18.11.2021: QUADRA-H 01.12.022 CEMENTLESS, HA COATED STD STEM SIZE 2 (K082792) LOT 135659: (B)(4). EXPIRATION DATE: 2018-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    AT 7 YEARS 8 MONTHS, THE SURGEON REVISED ALL IMPLANTS DUE TO MOBILIZATION OF THE STEM AND SHELL CAUSED BY GRANULOMA. THE CAUSE OF GRANULOMA IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844046 VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.1150 135286 07630030807886

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention