BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    MDR report key: 9562263 · Received January 8, 2020

    Report

    Report Number
    3005180920-2019-01129
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 8, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 7 JANUARY 2020: LOT 166635: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2017. EXPIRATION DATE: 2022-02-07. 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. OTHER DEVICES INVOLVED IN THE EVENT. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 LOT. 171403 (K112115). BATCH REVIEW PERFORMED ON 7 JANUARY 2020: LOT 171403: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2017. EXPIRATION DATE: 2022-07-18. 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. LINER: IMPACT DM 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD LOT. 171727 (K092265) BATCH REVIEW PERFORMED ON 7 JANUARY 2020: LOT 171727: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2017. EXPIRATION DATE: 2022-07-09. 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 INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER WITH A MEDACTA LINER ALMOST 2 YEARS AND 2 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25190 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 166635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention