AMIStem H Femoral Stems 01.18.130Recalls & reported problems
Medacta International SA · AMIStem-H Std. # 0 · Class 2 · Implant
All models of AMIStem H Femoral Stems (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medacta AMIStem-H is an uncemented metal hip stem used in hip replacement surgery. Most of the 32 reports describe the stem gradually loosening in the bone — often years after the original operation — leading to pain, hip instability, and revision surgery to replace the stem and other components; some describe the bone not growing into the implant as expected, and one mentions the stem being undersized. There were no deaths, 31 injuries, and one malfunction. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07630030804069), received between Aug 2, 2017 and Mar 3, 2026 — classified as 31 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (12 reports).
1 other recall cover devices cleared under the same FDA submission (K093944, K250450); they may or may not involve this specific model.
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
- Loose or Intermittent Connection12
- Appropriate Device Problem Term/Code Not Available9
- Osseointegration Problem6
- Loosening of Implant Not Related to Bone-Ingrowth3
- Loss of Osseointegration2
- Adverse Event Without Identified Device or Use Problem1
- Device Slipped1
- Fracture1
Patient problems
- Inadequate Osseointegration13
- Joint Disorder6
- Pain4
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Aseptic loosening1
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Osseointegration Problem
AT ABOUT 10 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAINT DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 24494901 ↗InjuryJul 14, 2025Loss of Osseointegration; Loss of Osseointegration
REVISION FOR STEM LOOSENING AT ABOUT 11 YEARS FROM PRIMARY. DUE TO STEM LOOSENING THE PATIENT HAD HIP INSTABILITY. THE HEAD, THE STEM AND THE LINER HAVE BEEN REVISED SUCCESSFULLY. M-VIZION STEM IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493617 ↗InjuryJun 5, 2024Loss of Osseointegration; Loss of Osseointegration
REVISION FOR STEM LOOSENING, THE PATIENT HAD PAIN, AT ABOUT 5 YEARS AND 11 MONTHS POST PRIMARY, THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE STEM WAS REPORTED AS UNDERSIZED.
Patient problems: Inadequate Osseointegration
MAUDE report 19466538 ↗InjuryFeb 5, 2024Osseointegration Problem; Osseointegration Problem
AT ABOUT 6 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 18639659 ↗InjuryOct 20, 2023Osseointegration Problem; Osseointegration Problem
AT ABOUT 7 YEARS 3 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO STEM LOOSENING. STEM AND HEAD SUCCESSFULLY REVISED.
Patient problems: Inadequate Osseointegration
MAUDE report 17974891 ↗InjurySep 15, 2023Osseointegration Problem; Osseointegration Problem
AT ABOUT 8 YEARS AND 4 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE STEM. THE SURGEON REVISED SUCCESSFULLY ALL THE COMPONENTS.
Patient problems: Inadequate Osseointegration
MAUDE report 17756462 ↗InjuryDec 15, 2022Osseointegration Problem; Osseointegration Problem
REVISION SURGERY FOR STEM LOOSENING AT ABOUT 6 YEARS AND 2 MONTHS FROM PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15987448 ↗InjuryJul 21, 2022Loose or Intermittent Connection
REVISION SURGERY WAS PERFORMED 3 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY DUE TO STEM LOOSENING. STEM AND HEAD REVISED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 15075383 ↗InjuryJul 7, 2022Osseointegration Problem; Osseointegration Problem
AT ABOUT 7 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 14942336 ↗InjuryMar 17, 2022Loose or Intermittent Connection
HEAD AND STEM WERE REVISED FOLLOWING STEM LOOSENING 10 YEARS AFTER PRIMARY.
Patient problems: Inadequate Osseointegration
MAUDE report 13802613 ↗InjuryMar 4, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 6 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 13665598 ↗InjuryAug 23, 2021Loose or Intermittent Connection
REVISION SURGERY 4 YEARS AND 7 MONTHS AFTER PRIMARY DUE TO STEM LOOSENING. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 12352961 ↗InjuryMay 25, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY HAS BEEN PERFORMED 5 YEARS AD 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION.
Patient problems: Inadequate Osseointegration
MAUDE report 11876944 ↗InjuryMar 29, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 4 YEARS 11 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 11581254 ↗InjuryDec 12, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY FOR STEM LOOSENING 5 YEARS AND 9 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.
Patient problems: Insufficient Information
MAUDE report 10996079 ↗InjuryDec 1, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN AFTER 2 YEARS AND 7 MONTHS FROM THE PRIMARY SURGERY REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE AMISTEM-H STD. # 0 WITH A QUADRA H SN STANDARD #0, AND THE 32MM BIOLOX DELTA HEAD S, WITH A 32MM BIOLOX DELTA HEAD M(THE LINER WAS NOT REVISED). THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 10928283 ↗InjurySep 9, 2020Loose or Intermittent Connection
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM 5 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 10507108 ↗InjuryJul 1, 2020Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT CAME IN REPORTING THIGH PAIN AFTER 4 YEARS AND 4 MONTHS FROM THE PRIMARY DUE TO STEM LOOSENING (PROXIMALLY) AND POTTED (DISTALLY). 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 10217851 ↗InjuryJun 25, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED 3 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. THE SURGEON REVISED THE STEM.
Patient problems: Joint Disorder
MAUDE report 10193999 ↗InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem
ABOUT 6 YEARS AND A HALF AFTER PRIMARY REVISION SURGERY FOR PAIN AND RADIOLUCENCY AT STEM LEVEL. STEM, HEAD AND LINER REVISED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 9646942 ↗InjuryNov 27, 2019Loose or Intermittent Connection; Unstable
REVISION SURGERY PERFORMED 3 YEARS AND 5 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY CAUSED BY A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration; Joint Disorder
MAUDE report 9383333 ↗InjuryOct 18, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY PERFORMED ABOUT 6 YEARS AND 4 MONTHS AFTER PRIMARY DUE TO STEM MOBILIZATION. THE SURGERY WAS COMPLETED SUCCESSFULLY, HEAD AND STEM REVISED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9207274 ↗InjuryOct 16, 2019Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS HAVING PAIN SINCE 2016. PRIMARY SURGERY PERFORMED ON (B)(6) 2013. REVISION SURGERY PERFORMED ALMOST 5 YEARS AFTER THE PRIMARY DUE TO STEM MOBILIZATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 9195804 ↗InjuryMay 2, 2019Loose or Intermittent Connection
REVISION SURGERY AFTER 11 MONTHS FROM THE PRIMARY DUE TO PAIN. THE SURGEON CONFIRMED THE STEM WAS LOOSE DISTALLY BUT WAS WELL FIXED PROXIMALLY AND HE WAS UNABLE TO REMOVE THE STEM. THE SURGEON CHOSE TO REVISE THE HEAD AND PLACE BIOCOMPOSITE BEADS AROUND THE STEM TO AIDE IN BONE GROWTH. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 8573538 ↗InjuryApr 18, 2019Loose or Intermittent Connection
THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A LOOSE STEM 6 YEARS AND 9 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 8527541 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K093944, K250450. One submission often covers many models, so check the product and lot details in each record.
- Z-0791-2013 · Dec 17, 2012 · TerminatedMedacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur
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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