BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 15283224 · Received August 24, 2022

    Report

    Report Number
    3005180920-2022-00639
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    July 25, 2022
    Report Date
    August 24, 2022
    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 26 JULY 2022: LOT 2107100: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUNE-2021. EXPIRATION DATE: 2026-06-08. 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 ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 26-JUL-2022: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2012923. LOT 2012923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2021. EXPIRATION DATE: 2026-03-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER 2 SIMILAR REPORTED EVENTS DURING 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. AT ABOUT 8 MONTHS 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
    2324883 LINER: MPACT FLAT PE HC LINER Ø36/E HIP FLAT LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2107100 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention