BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60

    MDR report key: 19711167 · Received July 10, 2024

    Report

    Report Number
    3005180920-2024-00500
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807817
    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 18 JUNE 2024 LOT 2200450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2022. EXPIRATION DATE: 2027-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 2206397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 2027-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: QUADRA-P 01.12.145 QUADRA-P LAT STEM SIZE 5 (K181254) LOT 2202896: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2022. EXPIRATION DATE: 2027-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 DISTRIBUTED IN US) LOT 2206419: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 2027-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    HIP REVISION FOR INFECTION. AT ABOUT 1 YEAR AND 7 MONTHS FORM PRIMARY ALL IMPLANTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359122 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60 HIP ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 2200450 07630030807817

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention