BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 9557479 · Received January 7, 2020

    Report

    Report Number
    3005180920-2019-01133
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03-JAN-2020. LOT 19001468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2019. EXPIRATION DATE: 13.04.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 107 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 1903000. BATCH REVIEW PERFORMED ON 03-JAN-2020. LOT 1903000: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2019. EXPIRATION DATE: 02.07.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO AN OOZING AND BREAKING WOUND THAT IS NOT HEALING CORRECTLY 1 MONTH AFTER PRIMARY. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23990 LINER: MPACT FLAT PE HC LINER Ø36/F ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 1901468 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention