BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

    MDR report key: 14485453 · Received May 24, 2022

    Report

    Report Number
    3005180920-2022-00386
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 25, 2022
    Report Date
    July 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808036
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 MAY 2022. LOT 1910228: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2020. EXPIRATION DATE: 2025-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT. 1907335. BATCH REVIEW PERFORMED ON 02 MAY 2022. LOT 1907335: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2020. EXPIRATION DATE: 2025-01-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT. 1910311. BATCH REVIEW PERFORMED ON 02 MAY 2022. LOT 1910311: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2020. EXPIRATION DATE: 2025-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED:STEM: SMS SOLID 01.36.044 SMS SOLID STEM STD SIZE 4 (K181693) LOT. 182421. BATCH REVIEW PERFORMED ON 02 MAY 2022. LOT 182421: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2018. EXPIRATION DATE: 2023-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    ON 29 JUNE 2022 MEDACTA INTERNATIONAL BECOME AWARE THAT: THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT HARDWARE: MEDACTA HEAD AND SLEEVE, AND COMPETITOR CUP AND LINER.

    Description of Event or Problem · 0

    AT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    ON 29 JUNE 2022 MEDACTA INTERNATIONAL BECOME AWARE THAT: THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT HARDWARE: MEDACTA HEAD AND SLEEVE, AND COMPETITOR CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221269 CUP: VERSAFITCUP ACETABULAR SHELL Ø 48 CEMENTLESS ACETABULAR CUP MEH MEDACTA INTERNATIONAL SA 01.26.48MB 1910228 07630030808036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention