BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD IMPLANTS

    MDR report key: 23298461 · Received October 15, 2025

    Report

    Report Number
    3005180920-2025-01002
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2025. BALL HEADS: COCR 01.25.030 COCR BALL HEAD 12/14 Ø36 MM SIZE S (K080885) LOT 2010471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MARCH-2021. EXPIRATION DATE: 2026-02-18. 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. ADDITIONAL DEVICES REVISED: BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2025. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT. 2111814: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2021. EXPIRATION DATE: 2026-09-07. 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. CONCLUSIONS: 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 3 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER TO A DOUBLE MOBILITY SYSTEM TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019229 COCR BALL HEAD IMPLANTS COCR BALL HEAD 12/14 Ø36 MM SIZE S JDI MEDACTA INTERNATIONAL SA 01.25.030 2010471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention