BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø32/D

    MDR report key: 17190145 · Received June 23, 2023

    Report

    Report Number
    3005180920-2023-00441
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 26, 2023
    Report Date
    June 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    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 30-MAY-2023: LOT 2118345: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2022. EXPIRATION DATE: 2027-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 30-MAY-2023: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT 2201966: 180 ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2022. EXPIRATION DATE: 2027-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER AND THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944657 MPACT FLAT PE HC LINER Ø32/D HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 2118345 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention