BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 15320131 · Received August 30, 2022

    Report

    Report Number
    3005180920-2022-00660
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 30, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 AUGUST 2022. LOT 2103128: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2021. EXPIRATION DATE: 2026-MAR-23. 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 ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 11 AUGUST 2022. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2100270. LOT 2100270: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2021. EXPIRATION DATE: 2026-APR-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION PERFORMED 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. LINER AND HEAD REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148609 LINER: MPACT FLAT PE HC LINER Ø36/F LINER FLAT LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 2103128 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention