BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    MDR report key: 7365114 · Received March 23, 2018

    Report

    Report Number
    3005180920-2018-00177
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    February 22, 2018
    Report Date
    March 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 MARCH 2018. MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 REFERENCE 01.32.148MB; LOT 173219: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4 AUGUST 2017. EXPIRATION DATE: 2022-07-26. 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. DOUBLE MOBILITY HC LINER 28/DMD REFERENCE 01.26.2848MHC (K092265); LOT 166698:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JANUARY 2017. EXPIRATION DATE: 2022-01-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 REFERENCE 01.29.201 (K112115); LOT 170680: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MAY 2017. EXPIRATION DATE: 2022-05-14. 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. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208466 MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 173219 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention