BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 8560455 · Received April 29, 2019

    Report

    Report Number
    3005180920-2019-00319
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 APR 2019: LOT 150143: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-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 WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: LINER: MPACT DM 01.26.2850MHC DOUBLE MOBILITY HC LINER 28/DME (K092265), LOT 162319: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2016 EXPIRATION DATE: 2021-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT ((B)(4)). IN THE PAST IT WAS ALREADY REPORTED THAT THE PATIENT INVOLVED IN THIS CASE HAD AN INFECTION AND THAT A WASHOUT HAD BEEN PERFORMED, BUT WITHUOT REMOVING ANY IMPLANT ((B)(4)): NOW THE SURGEON DECIDED TO REMOVE ALL THE IMPLANTS AS THE INFECTION WAS STILL PRESENT). BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857), LOT 170152: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2017. EXPIRATION DATE: 2022-05-03. 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. IN THE PAST IT WAS ALREADY REPORTED THAT THE PATIENT INVOLVED IN THIS CASE HAD AN INFECTION AND THAT A WASHOUT HAD BEEN PERFORMED, BUT WITHUOT REMOVING ANY IMPLANT ((B)(4)): NOW THE SURGEON DECIDED TO REMOVE ALL THE IMPLANTS AS THE INFECTION WAS STILL PRESENT). CUP: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL Ø50 (K143453),LOT 168455: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2017. EXPIRATION DATE: 2022-03-20. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEAR AND 6 MONTHS AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED THE CUP, LINER, HEAD AND STEM AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355736 STEM: AMISTEM H HA COATED LAT STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 150143 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention