BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 4

    MDR report key: 10354963 · Received August 3, 2020

    Report

    Report Number
    3005180920-2020-00483
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    July 9, 2020
    Report Date
    August 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804397
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 JULY 2020: LOT 177122: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2018. EXPIRATION DATE: 2023-01-31. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTLESS THA, 2 MONTHS AFTER PRIMARY OPERATION. 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. ADDITIONAL IMPLANT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.1158 ACETABULAR SHELL CC TRIO NO-HOLE Ø 58 (K122911) LOT. 174469. BATCH REVIEW PERFORMED ON 20 JULY 2020: LOT 174469: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2017. EXPIRATION DATE: 2022-10-25. 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. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP CC TRIO 01.26.3248HCT FLAT PE HC LINER Ø 32 / F (K103352) LOT. 165956. BATCH REVIEW PERFORMED ON 20 JULY 2020: LOT 165956: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2016. EXPIRATION DATE: 2021-11-15. 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.

    Description of Event or Problem · 1

    THE HIP OF THE PATIENT WAS REVISED ON THE (B)(6) 2020 (2 MONTHS AFTER PRIMARY) DUE TO THE LOOSENING OF THE HIP STEM. INITIALLY, HE WANTED TO CHANGE ONLY THE STEM, BUT SINCE THE SURGEON DID A PUNCTURE AND DISCOVERED A LOW-GRADE INFECTION, HE DECIDED ALSO TO CHANGE THE CUP AND THE LINER. NO MORE INFORMATION ABOUT THE INFECTION AGENT IS AVAILABLE. IT IS UNKNOWN IF THE LOOSENING IS RELATED TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822576 STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.174 177122 07630030804397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention