BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/C

    MDR report key: 13468972 · Received February 7, 2022

    Report

    Report Number
    3005180920-2022-00088
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 15, 2022
    Report Date
    February 7, 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 21 JANUARY 2022: LOT 2108134: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2021. EXPIRATION DATE: 2026-07-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 2012911. BATCH REVIEW PERFORMED ON 21 JANUARY 2022: LOT 2012911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2021. EXPIRATION DATE: 2026-03-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 MONTH FROM PRIMARY 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
    487034 LINER: MPACT FLAT PE HC LINER Ø32/C ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3239HCT 2108134 07630030811845

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention