BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 5

    MDR report key: 11744397 · Received April 29, 2021

    Report

    Report Number
    3005180920-2021-00338
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 29, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720144
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 APRIL 2021. LOT 182545: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2018. EXPIRATION DATE: 2023-09-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: CUP: MPACT 01.32.156MB DOUBLE MOBILITY ACETABULAR SHELL Ø56 (K143453) LOT. 1900195. BATCH REVIEW PERFORMED ON 06 APRIL 2021. LOT 1900195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUNE-2019. EXPIRATION DATE: 2024-06-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT DM 01.26.2856MHC DOUBLE MOBILITY HC LINER 28/DMH (K092265) LOT. 1901458. BATCH REVIEW PERFORMED ON 06 APRIL 2021. LOT 1901458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2019. EXPIRATION DATE: 2024-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 1900794. BATCH REVIEW PERFORMED ON 06 APRIL 2021. LOT 1900794: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    SIGNS OF INFECTION 1 YEAR 6 MONTHS AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED SUCCESSFULLY ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641892 STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 5 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 182545 07630040720144

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention