BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 28 / B

    MDR report key: 19433083 · Received May 31, 2024

    Report

    Report Number
    3005180920-2024-00353
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 31, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 MAY 2024, LOT 123334: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2012. EXPIRATION DATE: 2017-OCT-10. 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. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 06 MAY 2024: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT. 151900 LOT 151900: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2015. EXPIRATION DATE: 2020-MAY-31. 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.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO JOINT LUXATION ABOUT 8 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY. LINER AND HEAD REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239281 LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 28 / B CEMENTLESS HIP ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 123334

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Required Intervention