BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 20448874 · Received October 15, 2024

    Report

    Report Number
    3005180920-2024-00817
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807336
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2024 LINER: (B)(4) DM 01.26.2852M DOUBLE MOBILITY LINER Ø 52/28 LOT 091604: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2009. EXPIRATION DATE: 2014-07-31. 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 COMPONENT INVOLVED: BALL HEADS: MECTACER 38.39.7175.255.00 BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (USA) (K073337) LOT 092211: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2009. EXPIRATION DATE: 2014-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) 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 DUE TO SUSPECTED PE HC LINER AND CERAMIC HEAD WEAR, AT ABOUT 14 YEARS 10 MONTHS. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360180 DOUBLE MOBILITY LINER HIP ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 01.26.2852M 091604 07630030807336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention