BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 15679057 · Received October 27, 2022

    Report

    Report Number
    3005180920-2022-00808
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    October 5, 2022
    Report Date
    October 27, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    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 OCTOBER 2022 LOT 2201701: (B)(4) MANUFACTURED AND RELEASED ON 23-FEB-2022. EXPIRATION DATE: 2027-FEB-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 11 OCTOBER 2022 BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2201975: (B)(4) MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-FEB-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942747 MPACT FLAT PE HC LINER Ø36/E HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2201701 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention