BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 52

    MDR report key: 15623331 · Received October 18, 2022

    Report

    Report Number
    3005180920-2022-00789
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 28, 2022
    Report Date
    October 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808098
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON SEPTEMBER 2022: LOT 154158: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2015. EXPIRATION DATE: 2020-11-07. 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. ADDITIONAL COMPONENTS INVOLVED: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT. 152601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2015. EXPIRATION DATE: 2020-09-30. 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. LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT. 153655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2015. EXPIRATION DATE: 2020-10-07. 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. STEM: AMISTEM H 01.18.131 HA COATED STD STEM SIZE 1 (K0939449) LOT. 152543: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEPT-2015. EXPIRATION DATE: 2020-09-01. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 YEARS AND 9 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340251 CUP: VERSAFITCUP ACETABULAR SHELL Ø 52 HIP ACETABULAR CUP MEH MEDACTA INTERNATIONAL SA 01.26.52MB 154158 07630030808098

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention