BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD

    MDR report key: 22229294 · Received June 17, 2025

    Report

    Report Number
    3005180920-2025-00565
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 22, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805202
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-05-2025: LOT 181553: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-06-2018 EXPIRATION DATE: 2023-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD (B)(4) AS LOT 181553A) WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 28-05-2025: LINER: IMPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2344524: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-12-2023 EXPIRATION DATE: 2028-12-09. 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. 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

    AT ABOUT 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND LACK OF OFFSET. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85901 COCR FEMORAL BALL HEAD COCR BALL HEAD 12/14 Ø36 MM SIZE S JDI MEDACTA INTERNATIONAL SA 01.25.030 181553 07630030805202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention