AMIStem H Femoral StemsRecalls & reported problems across all models

We found 20 models of AMIStem H Femoral Stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 679 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2017 and Sep 9, 2026 — classified as 2 deaths, 669 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (161 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

Most reported AMIStem H Femoral Stems problems

AMIStem H Femoral Stems models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AMIStem H Femoral Stems 01.18.133

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  116 reports
• AMIStem H Femoral Stems 01.18.132

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  1 death115 reports
• AMIStem H Femoral Stems 01.18.131

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  74 reports
• AMIStem H Femoral Stems 01.18.134

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  72 reports
• AMIStem H Femoral Stems 01.18.135

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 death57 reports
• AMIStem H Femoral Stems 01.18.143

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  42 reports
• AMIStem H Femoral Stems 01.18.130

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  32 reports
• AMIStem H Femoral Stems 01.18.144

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  28 reports
• AMIStem H Femoral Stems 01.18.142

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  23 reports
• AMIStem H Femoral Stems 01.18.136

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  22 reports
• AMIStem H Femoral Stems 01.18.145

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  22 reports
• AMIStem H Femoral Stems 01.18.137

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  21 reports
• AMIStem H Femoral Stems 01.18.141

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  13 reports
• AMIStem H Femoral Stems 01.18.140

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  12 reports
• AMIStem H Femoral Stems 01.18.146

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  11 reports
• AMIStem H Femoral Stems 01.18.098

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  7 reports
• AMIStem H Femoral Stems 01.18.147

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  6 reports
• AMIStem H Femoral Stems 01.18.138

  Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
  3 reports
• AMIStem H Femoral Stems 01.18.148

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  2 reports
• AMIStem H Femoral Stems 01.18.139

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report

Recent AMIStem H Femoral Stems adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Osseointegration Problem

  Revision surgery due to Amistem H loosening. Multiple tests for infection were performed, all of which were negative. The stem was easily removed manually by the surgeons, without the need for any extraction devices. A cemented competitor`s stem was successfully implanted.

  Patient problems: Aseptic loosening

  MAUDE report 50692324 ↗
• InjurySep 9, 2026Osseointegration Problem

  Revision surgery due to stem loosening after about 13 years and 4 months from primary. The surgeon revised the Medacta stem and head to a competitor stem and head, and revised the Head Biolox Delta dia.28 12/14-L to a Double Mobility HC Liner D 28/DMG.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 50692312 ↗
• InjurySep 9, 2026Osseointegration Problem

  At about 11 years and 8 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 a competitor stem and head, and revised the Versafitcup DM Liner HC 54/28 to a Double Mobility HC Liner D 28/DMG. The surgery was completed successfully.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 50692311 ↗
• InjuryJul 8, 2026Osseointegration Problem

  AT ABOUT 12 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 25747720 ↗
• InjuryJul 6, 2026Osseointegration Problem

  AT ABOUT 11 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE 36/F MPACT FLAT LINER TO A FACE CHANGING 10° PE HC LINER D 40/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 25714734 ↗
• InjuryJul 6, 2026Osseointegration Problem

  AT ABOUT 9 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON OBSERVED THAT THE CUP POSITION WAS NOT TO HIS PREFERENCE. THE SURGEON REVISED THE VERSAFITCUP CC 50 MM CUP TO A MPACT D 56 TWO-HOLE CUP, REVISED THE 36 MM COCR HEAD TO A 36 MM BIOLOX HEAD L, REVISED THE VERSAFITCUP CC TRIO 36/E LINER TO A D 36/F HOODED PE LINER, AND REVISED THE AMISTEM H STANDARD SIZE 1 STEM TO A M-VIZION D 16 MM L 140 MM STRAIGHT STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 25714728 ↗
• InjuryMay 27, 2026Osseointegration Problem

  AT ABOUT 13 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE STEM AND HEAD TO COMPETITOR STEM AND HEAD, AND REVISED THE LINER TO MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25297692 ↗
• InjuryMay 22, 2026Osseointegration Problem

  AT ABOUT 12 YEARS POST PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA FLAT PE HC LINER D 36/F TO A MEDACTA FLAT PE HC LINER D 40/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25253486 ↗
• InjuryMay 12, 2026Osseointegration Problem

  AT ABOUT 9 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR FALL. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25148938 ↗
• InjuryMay 5, 2026Osseointegration Problem

  AT ABOUT 8 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR FALL. THE SURGEON REVISED THE MEDACTA HOODED D 32/D LINER TO A FLAT D 32/D LINER AND REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25077231 ↗
• InjuryApr 20, 2026Implant subsidence

  AT ABOUT 10 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE PATIENT REPORTED NO TRAUMA. THE SURGEON REVISED THE MEDACTA LINER TO A MEDACTA LINER AND REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 24924647 ↗
• InjuryMar 31, 2026Implant subsidence

  AT ABOUT 9 YEARS AND 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN ASSOCIATED WITH A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA INDICATED. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE D 32 LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 24738820 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE PATIENT HAD PRIMARY SURGERY FOR A FEMUR FRACTURE AND THAT WAS THE SITE OF THE PAIN. ABOUT 10 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE AMISTEM SIZE 3 TO A SHORTER SMS SOLID STEM SIZE 9, AND REVISED THE 36MM BIOLOX HEAD M TO A 36MM BIOLOX HEAD L. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 24738813 ↗
• InjuryMar 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO STEM LOOSENING 9 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Aseptic loosening

  MAUDE report 24711056 ↗
• InjuryMar 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WITH REPLACEMENT OF A TOTAL HIP PROSTHESIS ABOUT 12 YEARS AFTER PRIMARY SURGERY DUE TO LOOSENING OF THE STEM.

  Patient problems: Aseptic loosening

  MAUDE report 24710922 ↗

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