BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C, CEMENTED STEM SIZE 0 STD

    MDR report key: 6860918 · Received September 13, 2017

    Report

    Report Number
    3005180920-2017-00512
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804250
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 11 SEPTEMBER 2017. LOT 155215: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 SEPTEMBER 2015. EXPIRATION DATE: 2020-09-09. 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 ACETABULAR SHELL Ø54 MULTI-HOLE, CODE 01.32.154MH, LOT. 133724 (K132879) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 FEBRUARY 2014. EXPIRATION DATE: 2018-12-31. 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. MPACT FLAT PE HC LINER Ø36/E, CODE 01.32.3644HCT, LOT. 153133 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 OCTOBER 2015. EXPIRATION DATE: 2020-09-19. 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 THIS LOT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0, CODE 01.29.209, LOT. 151164 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 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. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30, CODE 01.32.6530, LOT. 130452 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MARCH 2013. EXPIRATION DATE: 2018-01-31. 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 ITEMS OF THE SAME LOT. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20, CODE 01.32.6520, LOT. 150699 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 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 AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THIS LOT. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30, CODE 01.32.6530, LOT. 145878 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JANUARY 2015. EXPIRATION DATE: 2019-10-31. 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. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35, CODE 01.32.6535, LOT. 115666 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE THIRD SIMILAR EVENT REPORTED ON ITEMS OF THIS LOT (COMPLAINT (B)(4)).

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE PATIENT WAS ALSO INFECTED. THE INFECTION IS NOT BELIEVED TO HAVE CAUSED THE LOOSENING. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA PRODUCT. THE SURGEON PLANS TO IMPLANT A SPACER AT A LATER DATE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641967 AMISTEM C, CEMENTED STEM SIZE 0 STD CEMENTED FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 155215 07630030804250

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention