BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM ACETABULAR LINER

    MDR report key: 5412696 · Received February 5, 2016

    Report

    Report Number
    3005180920-2016-00021
    Event Type
    Injury
    Date Received
    February 5, 2016
    Date of Event
    January 6, 2016
    Report Date
    May 2, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 07 APRIL 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 13 JANUARY 2016 INCLUDES: SURGERY WAS COMPLETED SUCCESSFUL. CHANGE OF INLAY AND HEAD. NO X-RAY, NO PIECES, NO PATIENT DETAILS. BATCH REVIEW PERFORMED ON 02 FEBRUARY 2016. LOT. 152102: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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. CRCO BALL HEAD 12/14 Ø 28 SIZE M 0, CODE 01.25.012, LOT. 147303 (K072857) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 FEBRUARY 2015. EXPIRATION DATE: 2019-12-31. 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. AMISTEM C, CEMENTED STEM SIZE 8 STD, CODE 01.18.158, LOT 113064 (K103189) LOT 113064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 SEPTEMBER 2011. EXPIRATION DATE: 2016-08-31. 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 CC ACETABULAR SHELL CC Ø 54, CODE 01.26.54MB, LOT. 151049 (K083116) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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

    HEAD AND INLAY WILL BE EXCHANGED, BECAUSE OF FECAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71369 VERSAFITCUP DM ACETABULAR LINER DOUBLE MOBILITY PE LINER MEH MEDACTA INTERNATIONAL SA 152102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention