BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58

    MDR report key: 17412886 · Received July 28, 2023

    Report

    Report Number
    3005180920-2023-00604
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807800
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 JULY 2023: LOT 2248533: 32 ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-MAR-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 19 JULY 2023: SMS SOLID 01.36.052 SMS SOLID STEM STD SIZE 12 (K181693) LOT 2204985: 10 ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2022. EXPIRATION DATE: 2027-JUL-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2311347: 200 ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2023. EXPIRATION DATE: 2028-MAY-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 68 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MECTACER 01.29.414 CERAMIC LINER Ø 36 / F (NOT MARKETED IN US) LOT 2310194: 90 ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2023. EXPIRATION DATE: 2028-APR-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY THE IMPLANTS WERE REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968387 VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58 HIP CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 2248533 07630030807800

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention