BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0

    MDR report key: 12352961 · Received August 23, 2021

    Report

    Report Number
    3005180920-2021-00668
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 22, 2021
    Report Date
    September 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804069
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER. FEMORAL COMPONENT (STEM, HEAD AND LINER) REVISION PERFORMED 4 YEARS AND 7 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND LEVEL OF ACTIVITY IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON (B)(6) 2021. LOT 163086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-SEP-2016. EXPIRATION DATE: 2021-AUG-21. 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 2017. PIECE WAS RETURNED ON 5 AUGUST 2021. PATIENT IS 71 YEARS OLD.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 AUGUST 2021: LOT 163086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-SEP-2016. EXPIRATION DATE: 2021-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD. ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THIS LOT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEMORAL COMPONENT (STEM, HEAD AND LINER) REVISION PERFORMED 4 YEARS AND 7 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A YOUNG ((B)(6) YEAR OLD) WOMAN. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND LEVEL OF ACTIVITY IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION PERFORMED BY R&D MANAGER: THE STEM HAS BEEN EXPLANTED DUE TO LOOSENING. IT HAS BEEN PRIMARILY IMPLANTED AT BEGINNING (B)(6) 2016. LOOKING AT THE IMAGE IT IS VISIBLE THAT THE HA ON THE STEM BODY HAS BEEN COMPLETELY ABSORBED BY PATIENT BONE AS EXPECTED. THERE ARE SOME SIGNS AND SCRATCHES ON THE NECK PART PROBABLY DUE TO REVISION SURGERY. ALSO THE EXPLANTED CERAMIC HEAD IS VISIBLE IN THE PHOTO, WITH SOME SCRATCHES ON THE BOTTOM PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED STEM LOOSENING. VISUAL INSPECTION PERFORMED BY R&D MANAGER: DURING THIS ANALYSIS IT IS CONFIRMED WHAT REPORTED IN THE PRELIMINARY INVESTIGATION, NOTHING MORE TO ADD.

    Description of Event or Problem · 1

    REVISION SURGERY 4 YEARS AND 7 MONTHS AFTER PRIMARY DUE TO STEM LOOSENING. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250676 STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.130 163086 07630030804069

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R