AMIStem-P Collared 01.18.437Recalls & reported problems
Medacta International SA · AMIStem-P Collared Std. #7 · Class 2 · Implant
All models of AMIStem-P Collared (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040720267), received between Feb 17, 2023 and Apr 4, 2025 — classified as 4 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
- Appropriate Device Problem Term/Code Not Available1
- Device Appears to Trigger Rejection1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bone Fracture(s)2
- Implant Pain1
- Medical device site infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 21771300 ↗InjuryApr 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT 1 YEAR AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 19086583 ↗InjuryMay 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AT ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A GREATER TROCHANTER FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON FOUND THE STEM TO BE WELL FIXED AND PROCEEDED TO PLATE THE FRACTURE, REVISING THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 17008951 ↗InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION FOR FEMORAL PERI-PROSTHETIC FRACTURE, REASON UNKNOWN. AT 14 DAYS AFTER PRIMARY THE SURGEON REVISED THE STEM AND HEAD SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 16395232 ↗
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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