BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD

    MDR report key: 24871649 · Received April 14, 2026

    Report

    Report Number
    3005180920-2026-00331
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 14, 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 MARCH 2026. BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 D 36 MM SIZE M (K080885) LOT 2009343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2020. EXPIRATION DATE: 2025-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 166 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER D 36/F (K103721) LOT 2011808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.156SH ACETABULAR SHELL D 56 NO-HOLE (K132879) LOT 2008056: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-NOV-2020. EXPIRATION DATE: 2025-10-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 (B)(6) AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY DUE TO A GAP FORMING BETWEEN THE HEAD AND LINER. THE CAUSE IS UNKNOWN AS THERE WAS NO REPORTED TRAUMA. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA 36MM HEAD TO A 28MM HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81477 COCR FEMORAL BALL HEAD COCR BALL HEAD 12/14 Ø36 MM SIZE M JDI MEDACTA INTERNATIONAL SA 01.25.031 2009343 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention