BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/C

    MDR report key: 15843476 · Received November 22, 2022

    Report

    Report Number
    3005180920-2022-00874
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 31, 2022
    Report Date
    November 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811845
    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 7 NOVEMBER 2022: LOT 2111800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEPT-2021. EXPIRATION DATE: 2026-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 07-NOV-2022. BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 2203055: LOT 2203055: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2022. EXPIRATION DATE: 2027-MAY-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT IN 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 20 DAYS 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
    2687296 LINER: MPACT FLAT PE HC LINER Ø32/C FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 01.32.3239HCT 2111800 07630030811845

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention