BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 16590957 · Received March 22, 2023

    Report

    Report Number
    3005180920-2023-00182
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 22, 2023
    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 17 MARCH 2023. LOT: 2209945: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2022. EXPIRATION DATE: 2027-06-07. 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 INVOLVED IMPLANT. BATCH REVIEW PERFORMED ON 17 MARCH 2023 ON BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT: 2211911, LOT: 2211911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2022. EXPIRATION DATE: 2027-08-04. 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 2 MONTHS 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436215 LINER: MPACT FLAT PE HC LINER Ø36/F HIP FLAT HIGH-CROSS LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 2209945 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention