BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28

    MDR report key: 17486504 · Received August 9, 2023

    Report

    Report Number
    3005180920-2023-00641
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 9, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31-JUL-2023: LOT 2003321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2020. EXPIRATION DATE: 2025-07-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 31-JUL-2023: LOT 2009388: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JAN-2021. EXPIRATION DATE: 2026-01-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. STEM: MASTERLOC 01.39.007 CEMENTLESS TI COATED STD STEM SIZE 7 ((B)(6)) LOT 171329: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2017. EXPIRATION DATE: 2022-09-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY COMPETITOR HIP SURGERY ON AN UNKNOWN DATE. ON (B)(6) 2021, THE PATIENT CAME IN FOR UNKNOWN REASONS AND HAD A PARTIAL REVISION TO A MEDACTA STEM, HEAD AND LINER THAT WAS MATCHED TO THE INTERNAL DIAMETER OF THE EXISTING ACETABULAR IMPLANT FROM THE INITIAL RESURFACING SURGERY. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO THE DEVELOPMENT OF A PSEUDO TUMOR THAT FORMED IN THE PELVIS, BEHIND THE ACETABULAR IMPLANT. THE SURGEON REVISED THE COMPETITOR CUP AND MEDACTA STEM, HEAD AND LINER TO ALL NEW MEDACTA COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTE: IT HAS BEEN REPORTED THAT THERE WERE NO ISSUES WITH MEDACTA IMPLANTS, THE SURGEON NEEDED TO REMOVE EVERYTHING TO GAIN EXPOSURE TO THE TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099571 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28 HIP DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 2003321 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention