BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DOUBLE MOBILITY HC LINER Ø 50/28

    MDR report key: 17649308 · Received August 30, 2023

    Report

    Report Number
    3005180920-2023-00652
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 30, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-AUG-2023 LOT 2302831: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2023. EXPIRATION DATE: 2028-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 52 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: CUP: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL Ø50 (K143453) LOT. 2247253: 32 ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2023. EXPIRATION DATE: 2028-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ON THE SAME DAY OF THE PRIMARY, THE PATIENT SUSTAINED A JOINT DISLOCATION. THE SURGEON PERFORMED SURGERY ON THE PATIENT AGAIN AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680142 LINER: MPACT DOUBLE MOBILITY HC LINER Ø 50/28 ACETABULAR LINER DOUBLE MOBILITY MEH MEDACTA INTERNATIONAL SA 2302831 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention