BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DM CONVERTER

    MDR report key: 22060635 · Received May 21, 2025

    Report

    Report Number
    3005180920-2025-00464
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030812330
    PMA / PMN Number
    K131458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 MAY 2025 LOT 131964B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2018. EXPIRATION DATE: 2023-02-12. 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. ADDITIONAL DEVICES INVOLVED: BALL HEADS: MECTACER 01.29.241A MECTACER SLEEVE 12/14 SIZE M (K131518) LOT. 180556 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-05-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.230H MECTACER HEAD BIOLOX OPTION 12/14 Ø 28 (K131518) LOT. 186573 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-NOV-2018. EXPIRATION DATE: 2023-10-30. 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. LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT. 1810744 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2019. EXPIRATION DATE: 2024-01-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: AMISTEM H 01.18.144 HA COATED LAT STEM SIZE 4 (K093944) LOT. 112646 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2011. EXPIRATION DATE: 2016-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT CAME IN COMPLAINING OF INSTABILITY AND THE HEAD AND LINER WAS REVISED ON (B)(6) 2016. ON (B)(6) 2019, 2 YEARS AND 9 MONTHS FROM THE LAST REVISION, THE PATIENT CAME IN REPORTING TIGHTNESS AND SORENESS DUE TO THE INCREASED LENGTH AND ASSOCIATED OFFSET WITH THE LONGER HEAD FROM THE PREVIOUS REVISION. THE REVISION SURGERY HAS BEEN COMPLETED SUCCESSFULLY. THE BALL HEAD AND LINER HAVE BEEN REVISED. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING THIGH PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724243 MPACT DM CONVERTER LINER: MPACT DM CONVERTER LINER G/DMF MEH MEDACTA INTERNATIONAL SA 01.32.4452MC 131964B 07630030812330

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention