AMIStem H Collared Femoral StemsRecalls & reported problems across all models
Medacta International SA · 17 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 92
- Recalls
- 0
We found 17 models of AMIStem H Collared Femoral Stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2017 and Aug 27, 2026 — classified as 92 injuries, 1 malfunction.
The most frequently reported specific device problem is “Osseointegration Problem” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AMIStem H Collared Femoral Stems problems
Device problems
- Osseointegration Problem23
- Appropriate Device Problem Term/Code Not Available19
- Loose or Intermittent Connection12
- Fracture9
- Loosening of Implant Not Related to Bone-Ingrowth8
- Adverse Event Without Identified Device or Use Problem6
- Device Operates Differently Than Expected4
- Device Slipped3
Patient problems
- Joint Disorder23
- Inadequate Osseointegration22
- Pain16
- Bone Fracture(s)9
- Aseptic loosening6
- Failure of Implant6
- Unspecified Infection6
- Implant Pain5
AMIStem H Collared Femoral Stems models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMIStem H Collared Femoral Stems 01.18.232Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented15 reports
- AMIStem H Collared Femoral Stems 01.18.233Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate15 reports
- AMIStem H Collared Femoral Stems 01.18.231Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate11 reports
- AMIStem H Collared Femoral Stems 01.18.234Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented10 reports
- AMIStem H Collared Femoral Stems 01.18.230Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented9 reports
- AMIStem H Collared Femoral Stems 01.18.235Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate6 reports
- AMIStem H Collared Femoral Stems 01.18.244Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate5 reports
- AMIStem H Collared Femoral Stems 01.18.243Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- AMIStem H Collared Femoral Stems 01.18.239Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- AMIStem H Collared Femoral Stems 01.18.241Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- AMIStem H Collared Femoral Stems 01.18.242Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- AMIStem H Collared Femoral Stems 01.18.229Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- AMIStem H Collared Femoral Stems 01.18.236Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- AMIStem H Collared Femoral Stems 01.18.237Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- AMIStem H Collared Femoral Stems 01.18.240Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
- AMIStem H Collared Femoral Stems 01.18.247Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- AMIStem H Collared Femoral Stems 01.18.248Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
Recent AMIStem H Collared Femoral Stems adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Osseointegration Problem
At9 years 6 months from the primary, the patient came in presenting instability due to a loose stem and the cause is unknown. The surgeon revised the Amistem H collared 00 stem and 28mm Biolox Head S to a competitor stem and head. The surgeon revised the DM Liner HC 52/28 to a Double Mobility HC Liner D 28/DMF. The surgery was completed successfully.
Patient problems: Aseptic loosening
MAUDE report 50474970 ↗InjuryJul 10, 2026Osseointegration Problem
REVISION SURGERY DUE TO STEM LOOSENING AFTER ABOUT 7 YEARS AND 6 MONTHS FROM PRIMARY. THE SURGEON REVISED THE AMISTEM H COLLARED STANDARD SIZE 4 TO A MONOBLOCK STEM D 13MM L 190MM STD, REVISED THE 36MM BIOLOX DELTA HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE, AND REVISED THE HOODED PE HC LINER D 36/F TO A FLAT PE HC LINER D 40/F AT HIS DISCRETION. XRAYS ARE UNAVAILABLE.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 25778117 ↗InjuryMay 13, 2026Osseointegration Problem
AT ABOUT 7 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO COMPETITOR DEVICES AND REPLACED THE MEDACTA LINER WITH A SAME-SIZE LINER.THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTS OF TRAUMA.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 25160336 ↗InjuryFeb 12, 2026Osseointegration Problem
AT ABOUT 6 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 24321116 ↗InjuryDec 18, 2025Osseointegration Problem; Osseointegration Problem
AT ABOUT 9 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 23836919 ↗InjuryNov 18, 2025Osseointegration Problem; Osseointegration Problem
AT ABOUT 10 YEARS AND 10-MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER TO MEDACTA COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 23579772 ↗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 ↗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 ↗InjuryJan 16, 2025Osseointegration Problem; Osseointegration Problem
PRIMARY SURGERY ON (B)(6) 2016, PATIENT FALL ON 2022, PAIN WORSENED ON (B)(6) 2024. ON RADIOGRAPHY STEM LOOSENING AND SUBSIDENCE CONFIRMED. ON (B)(6) 2024, ABOUT 8 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21168800 ↗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 ↗InjuryJun 13, 2024Osseointegration Problem; Osseointegration Problem
AT ABOUT 10 YEARS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.
Patient problems: Inadequate Osseointegration
MAUDE report 19527585 ↗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 ↗InjuryMar 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
AT 8 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISTALLY POTTED 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 18984914 ↗InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem
AT ABOUT 8 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 18516285 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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