AMIStem H Collared Femoral Stems 01.18.243Recalls & reported problems
Medacta International SA · AMIStem Collared HA coated stem Size 3 LAT · 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
- 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 07630030804687), received between Jul 20, 2017 and Nov 26, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (3 reports).
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
- Osseointegration Problem3
- Failure To Adhere Or Bond1
Patient problems
- Implant Pain1
- Inadequate Osseointegration1
- Joint Disorder1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Radiolucent Lines1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2024Osseointegration Problem; Osseointegration Problem
REVISION SURGERY FOR PAIN AND THE SURGEON NOTICED RADIOLUCENCY AROUND STEM COMPONENT. AT ABOUT 6 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain; Radiolucent Lines
MAUDE report 20786671 ↗InjuryOct 1, 2024Osseointegration Problem; Osseointegration Problem
AT ABOUT 2 YEARS 7 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO STEM LOOSENING. ALL COMPONENTS WERE REVISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20341696 ↗InjuryMar 27, 2024Osseointegration Problem; Osseointegration Problem
AT ABOUT 9 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.
Patient problems: Inadequate Osseointegration
MAUDE report 18984933 ↗InjuryJul 20, 2017Failure To Adhere Or Bond
THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE LOOSENING WAS DUE TO POOR BONE QUALITY. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS ARE NOT AVAILABLE.
Patient problems: Joint Disorder; Pain
MAUDE report 6727727 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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