BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 13058798 · Received December 22, 2021

    Report

    Report Number
    3005180920-2021-01026
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    December 6, 2021
    Report Date
    December 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    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 13 DECEMBER 2021 LOT 2103126: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-APR-2021. EXPIRATION DATE: 2026-MAR-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2100271 LOT 2100271: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2021. EXPIRATION DATE: 2026-04-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 1 MONTH AFTER THE PRIMARY SURGERY, 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
    1965713 LINER: MPACT FLAT PE HC LINER Ø36/E HIP ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2103126 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention