BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO Ø 48

    MDR report key: 8573531 · Received May 2, 2019

    Report

    Report Number
    3005180920-2019-00327
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 2, 2019
    Report Date
    May 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807756
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 MAY 2019: LOT 182553: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2018. EXPIRATION DATE: 2023-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: LINER: CC E CC LIGHT 01.26.3239HCT FLAT PE HC LINER Ø 32 / C (K120531), LOT 182621: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2018. EXPIRATION DATE: 2023-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 121 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115), LOT 180532: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2018. EXPIRATION DATE: 2023-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    INVOLVED IMPLANTS LOTS ARE NOT AVAILABLE UP TODAY, NO REVIEW OF THE RELATED DOCUMENTATION COULD HAVE BEEN PERFORMED.

    Description of Event or Problem · 1

    ON APRIL 2ND WE WERE INFORMED ABOUT A REVISION PERFORMED ON APRIL 23RD, 2 MONTHS FROM THE PRIMARY DUE TO HIP DISLOCATION (HEAD FROM LINER). THE CUP WAS NOT SEATED SUFFICIENTLY, ANTEVERTED TO 45 DEGREES AND ACETABULAR APPEARING UNDER-REAMED. REVISION SURGERY HAS BEEN PERFORMED WITH POST/LATERAL APPROACH, NO INFECTION HAS BEEN DETECTED AND THE PATIENT WAS ELECTED TO LEAVE THE STEM AND THE HEAD IN SITU. POLY, CUP AND ONE SCREW WERE REMOVED. REVISION SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367765 CUP: VERSAFITCUP CC TRIO Ø 48 CEMENTLESS ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 182553 07630030807756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention