BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED LAT STEM SIZE 0

    MDR report key: 14496130 · Received May 25, 2022

    Report

    Report Number
    3005180920-2022-00387
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803789
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. LATE INFECTION IN CEMENTED THA, 3 YEARS AFTER PRIMARY OPERATION. EARLY INFECTION HAPPENED AFTER PRIMARY SURGERY TREATED DURING THE FIRST REVISION. A RE-INFECTION WAS NOTICED DURING A FOLLOW-UP VISIT, 3 YEARS AFTER PRIMARY SURGERY. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEW PERFORMED ON 02 MAY 2022. LOT 1900031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MARCH-2019. EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS REVISED: BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36 (K131518) LOT. 167066: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2016. EXPIRATION DATE: 2021-11-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018. STEM: AMISTEM C 01.18.100 CEMENTED LAT STEM SIZE 0 (K103189) LOT. 141489B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2019. EXPIRATION DATE: 2024-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K1121159) LOT. 1810808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2019. EXPIRATION DATE: 2024-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2019. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD. THE SURGEON NOTICED A RE-INFECTION WHEN THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2022. THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY ON MAY 2, 2022 AND THE SURGEON REVISED ONLY THE COMPETITOR CUP. THE LOTS 1900031 AND 167066 REPORTED IN THE INITIAL REPORT, WERE NOT REVISED.

    Description of Event or Problem · 0

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2019. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD. THE SURGEON NOTICED A RE-INFECTION WHEN THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2022. THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY ON (B)(6) 2022.

    Description of Event or Problem · 0

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2019. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD. THE SURGEON NOTICED A RE-INFECTION WHEN THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2022. THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY ON MAY 2, 2022 AND THE SURGEON REVISED ONLY THE COMPETITOR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204304 STEM: AMISTEM C CEMENTED LAT STEM SIZE 0 HIP STEM CEMENTED LZO MEDACTA INTERNATIONAL SA 01.18.100 1900031 07630030803789

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention