BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø 54 TWO-HOLES

    MDR report key: 5973221 · Received September 23, 2016

    Report

    Report Number
    3005180920-2016-00482
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    August 24, 2016
    Report Date
    September 23, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 160474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-05-22. 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 INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 23 SEPTEMBER 2016 AND INCLUDES: THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. ALL IMPLANTS (CUP, LINER, STEM, HEAD) WERE REMOVED DUE TO INFECTION. THIS IS A STAGE 1 REVISION AND PATIENT WILL UNDERGO ANOTHER SURGERY (APPROX 6 / 8 WEEKS) TO REPLACE IMPLANTS WHEN THE INFECTION HAS CLEARED. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT WILL REQUIRE A REVISION SURGERY TO REMOVE THE CUP DUE TO INFECTION CAUSING LOOSENING OF CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624322 MPACT ACETABULAR SHELL Ø 54 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 160474

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention