BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H COATED STD SIZE 5

    MDR report key: 9846882 · Received March 18, 2020

    Report

    Report Number
    3005180920-2020-00164
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 18, 2020
    Report Date
    August 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 15-MAY-2020 WE WERE INFORMED THAT DEVICES ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    ON 15-MAY-2020 WE WERE INFORMED THAT DEVICES ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020 LOT 151390: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50 (K083116) LOT 151045: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2015. ON (B)(6) 2015, HEAD AND LINER WERE REVISED FOLLOWING SIGNS OF INFECTON. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN FOR A CHECK-UP AND THE X-RAYS INDICATED LOOSENING OF IMPLANTS (CUP AND STEM). THE SURGEON REVISED THE CUP, LINER, STEM, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311705 STEM: AMISTEM H COATED STD SIZE 5 HIP UNCEMENTED STEM LZO MEDACTA INTERNATIONAL SA 151390

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention