AMIStem-P 01.18.413Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630040720120), received between Feb 24, 2020 and Feb 6, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AT THE LESSER TROCHANTER AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE AMISTEM-P SIZE 3 STEM TO AN AMISTEM-C SIZE 5 STEM, AND REVISED THE HEAD TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24276570 ↗
• InjuryAug 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION WITH AN UNKNOWN CAUSE. THE IMPLANTS WERE REMOVED AND REPLACED WITH A COMPETITOR ANTIBIOTIC CEMENT SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22894259 ↗
• InjuryOct 4, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED ABOUT 3 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM LOOSENING. STEM AND HEAD REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20366840 ↗
• InjuryJul 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 3 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION WHICH CAUSED STEM LOOSENING. NO MOBILIZATION OF THE ACETABULAR SHELL HAS BEEN DETECTED. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS AND IMPLANTED A M-VIZION STEM WITH VERSAFITCUP DM COMPONENTS AND CERAMIC BALL HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 19790171 ↗
• InjuryJun 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON WANTED TO REVISE THE PATIENT BECAUSE HE WAS NOT SATISFIED BY THE WAY HE INITIALLY IMPLANTED IMPLANTS DURING THE PRIMARY. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ISSUES WERE DETECTED WITH THE IMPLANTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17077538 ↗
• InjuryFeb 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 3 YEARS AND 3 MONTHS FROM PRIMARY FOR INFECTION. ALL DEVICES REVISED SUCCESSFULLY AND SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16332043 ↗
• InjuryDec 16, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTING PAIN. FROM THE XRAYS, AN EMPTY SPACE BETWEEN THE PROXIMAL EDGE OF THE PROSTHESIS AND THE BONE WAS NOTED (STEM WAS NOT MOBILIZED). THE STEM WAS REVISED ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15996275 ↗
• MalfunctionDec 23, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR STEM LOOSENING PERFORMED 1 YEAR AFTER PRIMARY. THE SURGEON REMOVED SUCCESSFULLY THE STEM, THE HEAD, AND THE SLEEVE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13076103 ↗
• InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOR STEM LOOSENING PERFORMED 1 YEAR AND 3 MONTHS AFTER PRIMARY.

  Patient problems: Insufficient Information

  MAUDE report 12758102 ↗
• InjuryAug 5, 2020Malposition of Device; Malposition of Device

  THE PATIENT CAME IN 9 DAYS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A FEMORAL FRACTURE DUE TO THE STEM BEING IN VARUS. THE STEM WAS OVERSIZED AND MALPOSITIONED. THE SURGEON REVISED THE STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10366324 ↗
• InjuryFeb 24, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER MORE THAN 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9744696 ↗