BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 16529554 · Received March 13, 2023

    Report

    Report Number
    3005180920-2023-00062
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 13, 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 23 FEBRUARY 2023: LOT 161630C: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2021. EXPIRATION DATE: 2026-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LOT 161630: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2016. EXPIRATION DATE: 2021-04-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 23 FEBRUARY 2023: LINER: MPACT 01.32.3644HCAT HOODED PE HC LINER Ø36/E (K132879) LOT 2202312: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MARCH-2022. EXPIRATION DATE: 2027-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED AT ABOUT 8 MONTHS AFTER PRIMARY DUE TO JOINT LUXATION (HEAD FROM LINER). THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576542 COCR BALL HEAD 12/14 Ø 36 SIZE M 0 HIP COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.031 161630C 07630030805219

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention