AMIStem-P Collared 01.18.441Recalls & reported problems
Medacta International SA · AMIStem-P Collared Lat. #1 · Class 2 · Implant
All models of AMIStem-P Collared (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 07630040720304), received between Jan 27, 2022 and Jul 9, 2026 — classified as 2 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
- Device Appears to Trigger Rejection1
- Output Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hypersensitivity/Allergic reaction1
- Implant Pain1
- Metal Related Pathology1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO TITANIUM ALLERGY AFTER ABOUT 9 MONTHS AFTER PRIMARY. THE SURGEON REMOVED ALL EXISTING IMPLANTS, CEMENTED A HOODED PE HC LINER D 36/E AND QUADRA-P CEMENTED LAT. SIZE 1 AND REVISED THE 32MM BIOLOX DELTA HEAD S TO A 36MM BIOLOX DELTA HEAD M. THE PATIENT HAD A FRACTURE SO THE TITANIUM CABLES WERE REPLACED WITH MBRACE CABLES. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Hypersensitivity/Allergic reaction; Implant Pain; Metal Related Pathology
MAUDE report 25763497 ↗InjuryJan 27, 2022Output Problem
THE PATIENT CAME IN 6 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN AND X-RAYS INDICATED RADIOLUCENCY'S AROUND THE STEM, BUT IT WAS NOT LOOSE. THE SURGEON REVISED THE STEM HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 13365844 ↗
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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