BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD

    MDR report key: 21227335 · Received January 24, 2025

    Report

    Report Number
    3005180920-2025-00008
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 24, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805141
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-JAN-2025: LOT 2243694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-12-2022. EXPIRATION DATE: 2027-12-01. 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 REVISED. BATCH REVIEWS PERFORMED ON 09-JAN-2025: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT 2417988: 75 ITEMS MANUFACTURED AND RELEASED ON 03-09-2024. EXPIRATION DATE: 2029-07-30. 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: MPACT DM 01.32.4452CF DM CONVERTER G/DMF - TIN COATED (K211891) LOT 2401967: 20 ITEMS MANUFACTURED AND RELEASED ON 02-09-2024. EXPIRATION DATE: 2029-07-24. 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. ROOT CAUSE INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED HEAD, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 3005180920-2024-01131. ON (B)(6) 2025 THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663454 COCR FEMORAL BALL HEAD COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5 JDI MEDACTA INTERNATIONAL SA 01.25.015 2243694 07630030805141

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention