BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    MDR report key: 7540699 · Received May 24, 2018

    Report

    Report Number
    3005180920-2018-00360
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    December 22, 2017
    Report Date
    April 25, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 MAY 2018; LOT 170134: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 MAY 2017. EXPIRATION DATE: 2022-04-23 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. AMISTEM H HA COATED STD STEM SIZE 1 REFERENCE 01.18.131 (K093944); LOT 148430: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MARCH 2015. EXPIRATION DATE: 2020-02-29; 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. COCR BALL HEAD 12/14 Ø 32 SIZE XXL +10.5 REFERENCE 01.25.025 (K072857); LOT 162371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 JULY 2016. EXPIRATION DATE: 2021-06-21; 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 Ø32/D REFERENCE 01.32.3241HCT (K103721); LOT 171736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JULY 2017. EXPIRATION DATE: 2022-07-14. 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

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2017. IN (B)(6) 2017 CAME IN DUE TO SIGNS OF INFECTION AND THE SURGEON PERFORMED AN I&D AND SWAPPED THE HEAD AND LINER. THE PATHOGEN IS UNKNOWN. (B)(4). ON (B)(6) 2018 THE PATIENT IS BEING REVISED FOR INFECTION [STAPHILOCOCCUS]. THE SURGEON REVISED ALL COMPONENTS AND IMPLANTED A SPACER CONTAINING A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383995 MPACT ACETABULAR SHELL Ø50 TWO-HOLES ACETABULAR SHELL Ø50 TWO-HOLES LPH MEDACTA INTERNATIONAL SA 170134 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention