BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 4 STD

    MDR report key: 6996131 · Received November 2, 2017

    Report

    Report Number
    3005180920-2017-00625
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 2, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030826733
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 06 OCTOBER 2017 WE WERE INFORMED THAT THE PATIENT WILL NOT BE REVISED, BECAUSE HE IS BACK IN JAIL ON WORK RELEASE ON 09 OCTOBER 2017 IT WAS CONFIRMED THAT THE PATIENT IS UNABLE TO RETURN TO THE HOSPITAL DUE TO COURT SENTENCE: BACK IN JAIL UNTIL EARLY NEXT YEAR. BATCH REVIEWS PERFORMED ON 30 OCTOBER 2017. LOT 151442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0, CODE 01.29.202, LOT. 151721 (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. VERSAFITCUP ACETABULAR SHELL Ø 56, CODE 01.26.56MB, LOT. 151050 (K083116) 60 ITEMS MANUFACTURED AND RELEASED ON 16 JULY 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 58 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 56/28, CODE 01.26.2856MHC, LOT. 152104 (K092265) 119 ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 114 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON PLANS TO REVISE ALL COMPONENTS ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777762 AMISTEM H, HA COATED STEM SIZE 4 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 151442 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention