AMIStem H Collared Femoral Stems 01.18.237Recalls & reported problems
Medacta International SA · AMIStem Collared HA coated stem Size 7 STD · Class 2 · Implant
All models of AMIStem H Collared Femoral Stems (17)
Data updated Oct 18, 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 07630030804625), received between Jul 17, 2020 and Jul 29, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inadequate Osseointegration1
- Joint Disorder1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2025Failure to Osseointegrate; Migration; Failure to Osseointegrate; Migration
AT ABOUT 8 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration
MAUDE report 22643029 ↗InjuryJul 17, 2020Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT CAME IN REPORTING PAIN DUE TO AN ASEPTIC LOOSENING OF THE STEM. 5 YEARS AND 11 MONTHS AFTER PRIMARY THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 10288682 ↗
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- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
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- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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