BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø 46

    MDR report key: 6583839 · Received May 23, 2017

    Report

    Report Number
    3005180920-2017-00501
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    April 25, 2017
    Report Date
    May 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05 MAY 2017 THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: LATE INFECTION IN THA, 1 YEAR AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEWS PERFORMED ON 17 MAY 2017. LOT 153605: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 OCTOBER 2015. EXPIRATION DATE: 2020-10-07. 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. COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5, CODE 01.25.124, LOT. 141035 (K080885) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 APRIL 2014. EXPIRATION DATE: 2019-03-31. 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. VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 46/22.2, CODE 01.26.2246MHC, LOT. 152686 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2015. EXPIRATION DATE: 2020-10-10. 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 C, CEMENTED STEM SIZE 0 STD, CODE 01.18.150, LOT. 150877 (K103189) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MAY 2015. EXPIRATION DATE: 2020-03-31. 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 INFECTION IS CONFIRMED AS E. COLI. THE SURGEON REVISED ALL MEDACTA COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE; EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366257 VERSAFITCUP ACETABULAR SHELL Ø 46 CEMENTLESS ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 153605

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention