BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD

    MDR report key: 23221255 · Received October 6, 2025

    Report

    Report Number
    3005180920-2025-00922
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    August 28, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805141
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 DECEMBER 2025. BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5 (K072857) LOT 1901505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUNE-2019. EXPIRATION DATE: 2024-06-12. 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. LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø28/DMF (K092265) LOT 2302832: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APRIL-2023. EXPIRATION DATE: 2028-03-25. 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 INFORMATION: D1 D2 D4 G4 H4.

    Additional Manufacturer Narrative · 0

    WAITING MORE DETAILS FROM THE BRANCH ABOUT THE PRODUCTS INVOLVED AND TYPE OF EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON 18 DEC 2019. SUBSEQUENTLY, THE HEAD DISLOCATED FROM THE LINER. ON (B)(6) 2022, THE SURGEON REVISED THE HEAD AND LINER. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON 28 AUG 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. ON (B)(6) 2023, THE SURGEON REVISED THE HEAD AND LINER AND IMPLANTED A DM CONVERTER. (B)(4). ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. ON (B)(6) 2025 THE SURGEON REVISED THE MEDACTA STEM WITH A COMPETITOR STEM, AND REVISED THE MEDACTA HEAD AND LINER TO A MEDACTA DM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158762 COCR FEMORAL BALL HEAD COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5 JDI MEDACTA INTERNATIONAL SA 01.25.015 1901505 07630030805141

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention