BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P STD STEM SIZE 3

    MDR report key: 19380011 · Received May 23, 2024

    Report

    Report Number
    3005180920-2024-00352
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    December 12, 2023
    Report Date
    May 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720021
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTS REVISED IN (B)(6) 2024: BATCH REVIEW PERFORMED ON 06-MAY-2024: LOT 2310314: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2023. EXPIRATION DATE: 2028-09-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56 (K103352) LOT 2315968: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2023. EXPIRATION DATE: 2028-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 2339386: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2023. EXPIRATION DATE: 2028-10-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE LINER INVOLVED IN THE COMPLAINT IS NOT MARKETED IN THE USA, ANYWAY WE REPORT THE BATCH REVIEW. LINER: MECTACER 01.29.414 CERAMIC LINER Ø 36 / F (NO US) LOT 2341479: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2023. EXPIRATION DATE: 2028-10-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THE REFENCE, LOT OF THE DEVICES REVISED IN DURING THE INTERMEDIATE REVISION SURGERY ARE NOT AVAILABLE. THE DATE OF THE INTERMEDIATE REVISION SURGERY IS NOT AVAILABLE. THEY WERE A VERSAFITCUP LINER AND A MECTACER BALL HEAD. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFARIS MANAGER: A THA REVISION SURGERY WAS PERFORMED 4 MONTHS AFTER THE PRIMARY IMPLANT. THE REPORTED REASON OF THE REVISION WAS INFECTION CAUSED BY STAPHYLOCOCCUS AUREUS. THE AVAILABLE X-RAY, CONDUCTED 1 MONTH BEFORE REVISION, SHOWS UNCERTAIN SIGNS OF BONE REMODELING PARTICULARLY IN THE ILIAC BONE AND ISCHIO-PUBIC BRANCH, BONE RAREFACTION AT THE GREATER TROCHANTER AND A POSSIBLE RADIOLUCENCY LINE IN THE MEDIAL ASPECT OF THE STEM. ALSO, AN INITIAL HETEROTOPIC OSSIFICATION IS VISIBLE ABOVE THE GREAT TROCHANTER AND UNCERTAIN SLIGHT CALCIFICATIONS ON THE MEDIAL SIDE. THESE SIGNS ARE INSUFFICIENT TO CONFIRM AN INFECTION DIAGNOSIS, WHICH CERTAINLY REQUIRED FURTHER INVESTIGATION. 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.

    Description of Event or Problem · 0

    THE PATIENT UNDERGONE PRIMARY SURGERY ON (B)(6) 2023. A FIRST REVISION SURGERY HAS BEEN PERFORMED ON UNKNOWN DATE AND FOR UNKNOWN CAUSES. CERAMIC LINER AND BALL HEAD HAVE BEEN EXPLANTED AND REVISED. ON (B)(6) 2024, THE PATIENT HAS BEEN REVISED A SECOND TIME DUE STAPHYLOCOCCUS AUREUS INFECTION. ALL THE COMPONENTS HAVE BEEN SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608245 AMISTEM-P STD STEM SIZE 3 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2310314 07630040720021

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention