BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM 48

    MDR report key: 13505691 · Received February 10, 2022

    Report

    Report Number
    3005180920-2022-00111
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    January 18, 2022
    Report Date
    February 10, 2022
    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 21 JANUARY 2022: LOT 2007401: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2020. EXPIRATION DATE: 2025-OCT-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 21 JANUARY 2022: STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK (K082792) LOT 2000291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2020. EXPIRATION DATE: 2025-MAY-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT 2007625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-NOV-2020. EXPIRATION DATE: 2025-OCT-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CERAMIC LINER WAS EXPLANTED, THE DEVICE IS NOT MARKETED IN THE USA.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO INFECTION 10 MONTHS AFTER THE PRIMARY SURGERY. ALL IMPLANTS REMOVED AND REVISED WITH COMPETITOR IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110823 VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM 48 HIP UNCEMENTED SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0048 2007401 07630030807756

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention