BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø56 TWO-HOLES

    MDR report key: 6406117 · Received March 15, 2017

    Report

    Report Number
    3005180920-2017-00112
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    February 14, 2017
    Report Date
    July 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 28 JUNE 2017 AND INCLUDES: ON (B)(6) 2017 THE SPACER WAS REMOVED AND PERMANENT PRODUCT WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 15 MARCH 2017. LOT 157827: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 APRIL 2016. EXPIRATION DATE: 2021-07-17. 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. MPACT FLAT PE HC LINER Ø40/F, CODE 01.32.4048HCT, LOT. 162407 (K122641) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 SEPTEMBER 2016. EXPIRATION DATE: 2021-07-04. 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. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30, CODE 01.32.6530, LOT. 163602 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-18. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189225 MPACT ACETABULAR SHELL Ø56 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 157827

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention