AMIStem H Collared Femoral Stems 01.18.239Recalls & reported problems
Medacta International SA · AMIStem Collared HA coated stem Size 9 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
- 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 07630030804649), received between Aug 17, 2018 and May 21, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Implant subsidence1
- Loose or Intermittent Connection1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
- No Code Available1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2025Implant subsidence; Implant subsidence
AT ABOUT 9 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND HEAD WITH COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 22060630 ↗InjuryOct 25, 2018Loose or Intermittent Connection
ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY THE SURGEON PLANS A REVISION ON THE PATIENT HIP FOR STEM LOOSENING.
Patient problems: No Code Available
MAUDE report 8004509 ↗InjuryAug 17, 2018Fracture
THE PATIENT HAD A PRIMARY HIP ON (B)(6) 2018. DURING POST-OP IMAGING THE SURGEON NOTICED A FRACTURE OF THE FEMUR. THE SURGEON OPENED THE PATIENT ON THE SAME DAY TO CABLE THE FRACTURE. WHILE THE SURGEON WAS IN SURGERY HE DETERMINED THAT THE REVISION AFFECTED THE LIMB LENGTH, SO THE SURGEON REVISED THE HEAD SUCCESSFULLY.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 7793282 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- 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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