AMIStem-H Proximal Coating Femoral Stems 01.18.172Recalls & reported problems
Medacta International SA · AMIStem-H Proximal Coating Std. #2 · Class 2 · Implant
All models of AMIStem-H Proximal Coating Femoral Stems (11)
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 07630030804373), received between Apr 6, 2018 and Oct 19, 2018 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
Patient problems
- Joint Disorder2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 19, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY, 17 DAYS AFTER PRIMARY, DUE TO STEM SUBSIDENCE. THE SURGEON REMOVED THE STEM AND HEAD AND IMPLANTED ANOTHER COMPANY'S PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7984653 ↗InjuryMay 29, 2018Loose or Intermittent Connection
ABOUT 8 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT HIP DUE TO STEM LOOSENING. THE SURGEON SWAPPED SUCCESSFULLY THE STEM.
Patient problems: Joint Disorder
MAUDE report 7549087 ↗InjuryApr 6, 2018Device Dislodged or Dislocated
THE PATIENT CAME IN COMPLAINING OF PAIN 9 DAYS AFTER THE PRIMARY. THE SURGEON DETERMINED THAT THE STEM HAD SUBSIDED AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 7402526 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page