BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 18148911 · Received November 16, 2023

    Report

    Report Number
    3005180920-2023-00873
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    October 17, 2023
    Report Date
    November 16, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805219
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 OCTOBER 2023: LOT 186285: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2018. EXPIRATION DATE: 2023-10-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: STEM: QUADRA-C 01.12.40SN CEMENTED, MIRROR POLISHED STD STEM SIZE 0, SHORT NECK (K103189) LOT 2211699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEPT-2022. EXPIRATION DATE: 2027-08-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 3 MONTHS POST PRIMARY DUE TO HIP INFECTION. THE SURGEON REVISED THE STEM AND HEAD FROM MEDACTA AND THE ACETABULAR COMPONENTS FROM COMPETITOR. CEMENT SPACER WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108817 BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0 HIP BALL HEAD JDI MEDACTA INTERNATIONAL SA 186285 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention