BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD

    MDR report key: 23434015 · Received October 31, 2025

    Report

    Report Number
    3005180920-2025-01042
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805127
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13-10-2025. COCR 01.25.013 COCR BALL HEAD 12/14 Ø28 MM SIZE L (K072857) LOT. 092186: (B)(4) MANUFACTURED AND RELEASED ON 29-OCT-2009 EXPIRATION DATE: 2014-08-31. 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. LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø28/DMH (K092265) LOT. 091558: (B)(4) MANUFACTURED AND RELEASED ON 24-MAR-2010 EXPIRATION DATE: 2014-05-31. 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. STEM: AMISTEM H 01.18.135 AMISTEM-H STD. SIZE 5 (K093944) LOT. 092522: (B)(4) MANUFACTURED AND RELEASED ON 11-12-2009 EXPIRATION DATE: 2014-OCT-31. 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. DUE TO THE LACK OF INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE, WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 15 YEARS AND 5 MONTHS FROM PRIMARY THE PATIENT WAS REVISED DUE TO SUSPECTED POLY LINER WEAR IDENTIFIED DURING CT EXAM, ALSO USE OF METAL HEAD LED TO SUSPECT TRUNNIONOSIS. DURING REVISION TRUNNIONOSIS WAS CONFIRMED WHILE THE LINER DID NOT SEEM TO BE TOO WORN. METAL HEAD WAS SUBSTITUTED WITH A CERAMIC ONE AND LINER WITH AN HC ONE. STEM WAS NOT REVISED. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562901 COCR FEMORAL BALL HEAD COCR BALL HEAD 12/14 Ø28 MM SIZE L JDI MEDACTA INTERNATIONAL SA 01.25.013 092186 07630030805127

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention