BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT OFFSET 4MM PE HC LINER Ø36/G

    MDR report key: 19761737 · Received July 17, 2024

    Report

    Report Number
    3005180920-2024-00528
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040731133
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15-JUL-2024. LOT 2246042: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2023. EXPIRATION DATE: 2018-01-16. 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. OTHER DEVICES INVOLVED: CUP: MPACT 01.32.162DH ACETABULAR SHELL Ø62 TWO-HOLES (K132879) LOT 2301479: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2023. EXPIRATION DATE: 2028-05-17. 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.

    Description of Event or Problem · 0

    IN POST-OP RECOVERY, THE SAME DAY OF THE PRIMARY SURGERY, THE PATIENT SUFFERED A JOINT LUXATION BETWEEN OUR LINER AND COMPETITOR BALL HEAD. THE SURGEON REVISED THE COMPETITOR STEM AND HEAD, TWO MEDACTA SCREWS AND LINER AND REPOSITIONED THE MEDACTA CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362788 LINER: MPACT OFFSET 4MM PE HC LINER Ø36/G HIP LINER LPH MEDACTA INTERNATIONAL SA 2246042 07630040731133

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention