BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM COLLARED HA COATED STEM SIZE 1 STD

    MDR report key: 6878304 · Received September 20, 2017

    Report

    Report Number
    3005180920-2017-00529
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    August 25, 2017
    Report Date
    September 20, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804564
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01 DECEMBER 2017 WE WERE INFORMED BY THE COMPLAINER THAT THE SECOND STEP OF THE SURGERY HAS BEEN COMPLETED. THE SURGEON REVISED THE ABX SPACER AND IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 18 SEPTEMBER 2017. LOT 155245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JANUARY 2016. EXPIRATION DATE: 2021-01-02. 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 CC TRIO Ø 46, CODE 01.26.45.0046, LOT. 160097 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2016. EXPIRATION DATE: 2021-04-13. 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 FLAT PE HC LINER Ø 32 / C, CODE 01.26.3239HCT, LOT. 160851 (K120531) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 MAY 2016. EXPIRATION DATE: 2021-05-01. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4, CODE 01.29.204, LOT. 160547 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2016. EXPIRATION DATE: 2021-04-14. 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. CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 25, CODE 01.26.65.25, LOT. 154186 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 OCTOBER 2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THIS LOT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS POSITIVE FOR AN INFECTION. THE PATHOGEN WILL NOT BE DISCLOSED. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON 01 DECEMBER 2017 WE WERE INFORMED BY THE COMPLAINER THAT THE SECOND STEP OF THE SURGERY HAS BEEN COMPLETED. THE SURGEON REVISED THE ABX SPACER AND IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS POSITIVE FOR AN INFECTION. THE PATHOGEN WILL NOT BE DISCLOSED. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660235 AMISTEM COLLARED HA COATED STEM SIZE 1 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 155245 07630030804564

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention