BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 16494447 · Received March 7, 2023

    Report

    Report Number
    3005180920-2023-00132
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 MARCH 2023: LOT: 2009612: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-OCT-2020. EXPIRATION DATE: 2025-10-19. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 03 MARCH 2023: BALL HEADS: COCR 01.25.034 COCR BALL HEAD 12/14 Ø 36 SIZE XXL +10.5 (K080885) LOT: 172873: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2017. EXPIRATION DATE: 2022-09-10. 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.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER (36 TO 40 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61191 MPACT FLAT PE HC LINER Ø36/F HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 2009612 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention