BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 50

    MDR report key: 19297228 · Received May 13, 2024

    Report

    Report Number
    3005180920-2024-00318
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 13, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808067
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 APRIL 2024: LOT 2007397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2020. EXPIRATION DATE: 2025-11-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 25 APRIL 2024: LINER: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø 50/28 (K092265) LOT 1909377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-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 OTHER 2 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 2114358: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2022. EXPIRATION DATE: 2026-12-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: AMISTEM C 01.18.151 CEMENTED STD STEM SIZE 1 (K103189) LOT 2102130: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE PE PLUG IMPLANTED IN THE PATIENT IS NOT MARKETED IN THE USA. WE PERFORMED ANYWAY THE BATCH REVIEW, REPORTED HERE BELOW: MECTAPLUG 01.33.101 MECTAPLUG PE SIZE 1 () LOT 2117832: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MARCH-2022. EXPIRATION DATE: 2027-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: LATE INFECTION IN THA, 1 YEAR AND 11 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 0

    AT 1 YEAR AND 11 MONTHS FROM THE PRIMARY, HIP REVISION SURGERY ON THE RIGHT SIDE DUE TO INFECTION, WHICH CAUSED THE LOOSENING OF THE STEM. EXPLANTATION OF ALL THE COMPONENTS AND REIMPLANTATION OF A M-VIZION STEM 180MM, BODY 20/40MM AND A VERSAFITCUP DM 52 WITH DMF LINER 28 AND CERAMIC BALL HEAD 28 M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858776 CUP: VERSAFITCUP ACETABULAR SHELL Ø 50 HIP CEMENTLESS SHELL MEH MEDACTA INTERNATIONAL SA 2007397 07630030808067

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention