BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT HOODED PE HC LINER Ø36/E

    MDR report key: 9464962 · Received December 13, 2019

    Report

    Report Number
    3005180920-2019-01056
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812101
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 NOVEMBER 2019: LOT 1900229: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2019. EXPIRATION DATE: 2024-03-05. 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 IMPLANT INVOLVED INTO THE EVENT, BATCH REVIEW PERFORMED ON 28 NOVEMBER 2019. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 1902997. LOT 1902997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2019. EXPIRATION DATE: 2024-06-25. 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.

    Description of Event or Problem · 1

    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
    1261698 LINER: MPACT HOODED PE HC LINER Ø36/E LINER HOODED PE HC LPH MEDACTA INTERNATIONAL SA 1900229 07630030812101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention