BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD

    MDR report key: 20705340 · Received November 18, 2024

    Report

    Report Number
    3005180920-2024-00954
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805219
    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 28-OCT-2024: LOT 180329: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2018. EXPIRATION DATE: 2023-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 28-OCT-2024: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 182614: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2018. EXPIRATION DATE: 2023-07-11. 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. STEM: MASTERLOC 01.39.206 CEMENTLESS TI COATED LAT STEM SIZE 6 (K151531) LOT 177969: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2018. EXPIRATION DATE: 2023-03-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: 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 5 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611105 COCR FEMORAL BALL HEAD COCR BALL HEAD 12/14 Ø 36 SIZE M 0 JDI MEDACTA INTERNATIONAL SA 01.25.031 180329 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention