BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5

    MDR report key: 12331235 · Received August 17, 2021

    Report

    Report Number
    3005180920-2021-00656
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 19, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720045
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR FEW MONTHS AFTER PRIMARY CEMENTLESS THR, THE PATIENT FEELS A SUDDEN PAIN AND THE STEM NEEDS TO BE REMOVED. IT APPEARS FROM THE EXAMENS PERFORMED THAT THE POSSIBILITY OF AN INFECTION HAS NOT BEEN RULED OUT. IN FACT, IN THE RADIOGRAPHIC IMAGE AVAILABLE, A THICK RADIOLUCENT AREA IS CLEARLY VISIBLE IN THE PROXIMAL-MEDIAL AREA OF THE STEM, WHICH COULD INDICATE A PROBLEM OCCURRED DURING PREPARATION OR, MORE LIKELY, A SUBSEQUENT INFECTION. WE HAVE NO OTHER EXPLANATION TO OFFER FOR SUCH A RAPID AND SUDDEN LOSS OF MECHANICAL STABILITY, WHICH IS EXTREMELY UNUSUAL IF NOT EXCEPTIONAL. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. DURING THE ANALYSIS OF THE PHOTOS PROVIDED IT IS EVALUATED THAT SOME BLOOD RESIDUALS ARE PRESENT ON THE STEM BODY. LOOKING AT THE HA COATING IT IS VISIBLE THAT THE HA COATING IS PRESENT ON THE PROXIMAL PART OF THE STEM, WHILE IT HAS BEEN ABSORBED BY PATIENT BONE IN THE DISTAL PART (EVEN IF SOME HA RESIDUALS ARE PRESENT ALSO ON THE DISTAL STEM). THE PRESENCE OF THE HA COATING ON THE PROXIMAL PART OF THE STEM BODY IS UNEXPECTED, MEANING THAT THE STEM WAS NOT CORRECTLY OSSEOINTEGRATED WITH THE PATIENT BONE (6 MONTHS OF IMPLANTATION). THIS SHOULD BE THE POSSIBLE CAUSE OF THE REPORTED PATIENT PAIN. SOME SCRATCHES AND SIGNS ARE PRESENT ON THE NECK PART OF THE STEM, PROBABLY DUE TO THE REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE INCORRECT STEM OSTEOINTEGRATION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 JULY 2021: LOT 2000062: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2020. EXPIRATION DATE: 2025-APR-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY 6 MONTHS AFTER PRIMARY FOR STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227289 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.405 2000062 07630040720045

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention