BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50

    MDR report key: 16021054 · Received December 21, 2022

    Report

    Report Number
    3005180920-2022-00977
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    December 9, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807763
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 182557: 120 ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2018. EXPIRATION DATE: 2026-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 116 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2022. LINER: VERSAFITCUP CC TRIO 01.26.3644HCT FLAT PE HC LINER Ø 36 / E (K103352) LOT 183106: 65 ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2018. EXPIRATION DATE: 2023-07-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 183362: 200 ITEMS MANUFACTURED AND RELEASED ON 18-SEPT-2018. EXPIRATION DATE: 2023-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 197 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 4 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR'S IMPLANTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024353 CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 HIP ACETABULAR SHELL CC TRIO LZO MEDACTA INTERNATIONAL SA 01.26.45.0050 182557 07630030807763

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention