BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C CEMENTED STD STEM SIZE 0

    MDR report key: 8150505 · Received December 11, 2018

    Report

    Report Number
    3005180920-2018-00982
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 11, 2018
    Report Date
    December 11, 2018
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 DECEMBER 2018. LOT 154509: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-15. 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. OTHERS DEVICES INVOLVED: MPACT FLAT PE HC LINER Ø28/B, REFERENCE 01.32.2837HCT. LOT 166648: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 NOVEMBER 2016. EXPIRATION DATE: 2021-10-25. 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 Ø46 TWO-HOLES, REFERENCE 01.32.146DH. LOT 168434: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MARCH 2017 . EXPIRATION DATE: 2022-02-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 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 S -3.5, REFERENCE 01.29.201. LOT 172246: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 AUGUST 2017. EXPIRATION DATE: 2022-08-17. 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

    ABOUT 11 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR HIP INFECTION. STEM, HEAD, CUP AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993310 AMISTEM C CEMENTED STD STEM SIZE 0 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 154509 07630030804250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention