BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD

    MDR report key: 24276574 · Received February 6, 2026

    Report

    Report Number
    3005180920-2026-00087
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 6, 2026
    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 26 JANUARY 2026. BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 D 36 MM SIZE M (K080885) LOT 148649: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP CC TRIO 01.26.45.0052 VERSAFITCUP METALBACK CC TRIO D 52 MM (K103352) LOT 151063: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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

    AT ABOUT 10 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO METALLOSIS. THE SURGEON ALSO OBSERVED THAT THE CUP WAS LOOSE. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344290 COCR FEMORAL BALL HEAD COCR BALL HEAD 12/14 Ø36 MM SIZE M JDI MEDACTA INTERNATIONAL SA 01.25.031 148649 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention