BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 18266874 · Received December 5, 2023

    Report

    Report Number
    3005180920-2023-00995
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 13, 2023
    Report Date
    December 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    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 05 DECEMBER 2023 LOT 2248470: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MARCH-2023. EXPIRATION DATE: 2028-02-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 05 DECEMBER 2023 BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2304158 LOT 2304158: (B)(4) MANUFACTURED AND RELEASED ON 13-MARCH-2023. EXPIRATION DATE: 2028-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 121 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 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF 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
    2048251 LINER: MPACT FLAT PE HC LINER Ø36/E FLAT LINER PE HC LPH MEDACTA INTERNATIONAL SA 2248470 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention