BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/G

    MDR report key: 9114995 · Received September 25, 2019

    Report

    Report Number
    3005180920-2019-00799
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812156
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 AUGUST 2019. LOT 1810222: 40 ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 30 AUGUST 2019 . BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 1811841. LOT 1811841: 327 ITEMS MANUFACTURED AND RELEASED ON 07-APR-2019. EXPIRATION DATE: 2024-03-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 240 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER ALMOST 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914006 LINER: MPACT FLAT PE HC LINER Ø36/G FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 1810222 07630030812156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention