BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø28/B

    MDR report key: 15154907 · Received August 3, 2022

    Report

    Report Number
    3005180920-2022-00609
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    July 18, 2022
    Report Date
    August 3, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811531
    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 02 AUGUST 2022: LOT 1810214: 44 ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 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 02 AUGUST 2022 SCREWS: MPACT 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT 2208670: 314 ITEMS MANUFACTURED AND RELEASED ON 08-JUNE-2022. EXPIRATION DATE: 2027-05-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 70 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 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951649 LINER: MPACT FLAT PE HC LINER Ø28/B HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 01.32.2837HCT 1810214 07630030811531

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention