AMIStem-P 01.18.415Recalls & reported problems
Medacta International SA · AMIStem-P Lat. #5 · Class 2 · Implant
All models of AMIStem-P (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040720144), received between Apr 29, 2021 and Jul 1, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2025Osseointegration Problem; Osseointegration Problem
PATIENT UNDERWENT PRIMARY THR IN 2020 AND SOON REPORTED PAIN. DURING FOLLOWUP, XRAYS MODIFICATION OF THE FEMURAL BONE WERE NOTICED PREDICTING A POSSIBLE STEM MOBILIZATION. ON (B)(6) 2025, THE STEM WAS CONFIRMED AS MOBILIZED AND REVISED. M-VIZION STEM IMPLANTED AND LINER REVISED WITH DM CONVERTER TO IMPROVE ROM. SURGERY COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 22371285 ↗InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem
SIGNS OF INFECTION 1 YEAR 6 MONTHS AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED SUCCESSFULLY ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER.
Patient problems: Unspecified Infection
MAUDE report 11744397 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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