BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 6 STD

    MDR report key: 6215349 · Received December 30, 2016

    Report

    Report Number
    3005180920-2016-00690
    Event Type
    Injury
    Date Received
    December 30, 2016
    Report Date
    March 31, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 27 DECEMBER 2016. LOT 130604: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MAY 2013. EXPIRATION DATE: 2018-03-31. 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 ACETABULAR SHELL DIAM 58, CODE 01.26.58MB, LOT. 133457 (K083116), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE SAME LOT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5, CODE 01.29.201, LOT. 132943 (K112115), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 SEPTEMBER 2013. EXPIRATION DATE: 2018-07-31. 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. DOUBLE MOBILITY HC LINER DIAM 58/28, CODE 01.26.2858MHC, LOT. 131723 (K092265), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JUNE 2013. EXPIRATION DATE: 2018-04-30. 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. ADDITIONAL INFORMATION RECEIVED ON 29 DECEMBER 2016 AND INCLUDES: THE PATIENT HAS NOT RESCHEDULED A REVISION SURGERY YET. IT WILL BE EARLY IN 2017. DEVICE NOT YET EXPLANTED.

    Additional Manufacturer Narrative · 1

    THE SURGEON PLANNED TO REVISE ALL MEDACTA COMPONENTS AND IMPLANT AN ANTIBIOTIC SPACER BUT A REVISION SURGERY HAD NOT BEEN PLANNED, YET. TO DATE, MEDACTA HAS NOT RECEIVED ANY INFORMATION RELATED TO THE REVISION SURGERY. FOR THIS REASON, THE COMPLAINT IS CLOSED. IN CASE OF RECEIVING ANY UPDATE ABOUT THIS CASE, IT WILL BE COMMUNICATED TO FDA.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE PATIENT HAS AN INFECTION. THE INFECTION IS CONFIRMED. THE SURGEON PLANS TO REVISE ALL MEDACTA COMPONENTS AND IMPLANT AN ANTIBIOTIC SPACER. A REVISION IS NOT SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866401 AMISTEM H, HA COATED STEM SIZE 6 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 130604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention