AMIStem-P Collared 01.18.445Recalls & reported problems
Medacta International SA · AMIStem-P Collared Lat. #5 · Class 2 · Implant
All models of AMIStem-P Collared (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040720342), received between Feb 15, 2022 and Sep 8, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
- Device Appears to Trigger Rejection1
- Implant subsidence1
Patient problems
- Unspecified Infection2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2025Implant subsidence; Implant subsidence
AFTER 15 DAYS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON ISN'T SURE, BUT HE SUSPECTS OCCULT FRACTURE AT TIME OF PRIMARY.
Patient problems: Pain
MAUDE report 22991999 ↗InjuryNov 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 18109046 ↗InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 13535309 ↗
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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