BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM- P SHORT NECK STD STEM SIZE 3

    MDR report key: 12874441 · Received November 25, 2021

    Report

    Report Number
    3005180920-2021-00946
    Event Type
    Injury
    Date Received
    November 25, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971243675
    PMA / PMN Number
    K192126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 NOVEMBER 2021. LOT 2002211: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2020. EXPIRATION DATE: 2025-JUL-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. FEW DAYS AFTER PRIMARY CEMENTLESS THA A FRACTURE IS DETECTED AT XRAY ANALYSIS, FOLLOWING REPORT OF PAIN BY THE PATIENT. THE STEM HAS VISIBLY SUBSIDED. THIS SHOULD BE A CONSEQUENCE OF THE FRACTURE, BUT IT COULD ALSO BE A POTENTIAL CAUSE FOR THE FRACTURE. HOWEVER, THE STEM DOES NOT LOOK UNDERSIZED, SO A PRIMARY SUBSIDENCE IS NOT VERY LIKELY, ALBEIT STILL POSSIBLE. THERE IS NO MENTION IN THE REPORT OF A TRAUMATIC EVENT. IT IS POSSIBLE HOWEVER THAT THE FRACTURE HAS BEEN GENERATED DURING REHABILITATION, AND THE SUBSIDENCE TOOK PLACE SUBSEQUENTLY, BUT THERE ARE NO HARD FACTS TO SUPPORT THIS HYPOTHESIS.

    Description of Event or Problem · 0

    NO ISSUE WAS NOTED ON THE X-RAY AFTER PRIMARY SURGERY. AT 1 MONTH AFTER THE SURGERY, THE PATIENT CAME TO THE HOSPITAL REPORTING PAIN. THE SURGEON NOTICED A FRACTURE ON THE DISTAL PART OF THE FEMUR. THE POSSIBLE CAUSE IS STEM SUBSIDENCE AND THE CAUSE OF STEM SUBSIDENCE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773701 STEM: AMISTEM P AMISTEM- P SHORT NECK STD STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.463 2002211 07630971243675

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention