BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD

    MDR report key: 23876943 · Received December 23, 2025

    Report

    Report Number
    3005180920-2025-01317
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 17, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805219
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 DECEMBER 2025. BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 D 36 MM SIZE M (K080885) LOT 2429063: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2025. EXPIRATION DATE: 18-MAR-2030. 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 01.32.3648HCT FLAT PE HC LINER D 36/F (K103721) LOT 2513542: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2025. EXPIRATION DATE: 17-JUN-2030. 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

    AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531903 COCR FEMORAL BALL HEAD COCR BALL HEAD 12/14 Ø36 MM SIZE M JDI MEDACTA INTERNATIONAL SA 01.25.031 2429063 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention