AMIStem-PRecalls & reported problems across all models

We found 18 models of AMIStem-P by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2018 and May 22, 2026 — classified as 2 deaths, 145 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (31 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-P problems

AMIStem-P models

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

• AMIStem-P 01.18.403

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 death28 reports
• AMIStem-P 01.18.402

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  24 reports
• AMIStem-P 01.18.404

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  16 reports
• AMIStem-P 01.18.401

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  11 reports
• AMIStem-P 01.18.413

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  11 reports
• AMIStem-P 01.18.405

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  9 reports
• AMIStem-P 01.18.400

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  7 reports
• AMIStem-P 01.18.406

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  6 reports
• AMIStem-P 01.18.414

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  6 reports
• AMIStem-P 01.18.407

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  5 reports
• AMIStem-P 01.18.416

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 death5 reports
• AMIStem-P 01.18.408

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  4 reports
• AMIStem-P 01.18.417

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  4 reports
• AMIStem-P 01.18.409

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• AMIStem-P 01.18.411

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• AMIStem-P 01.18.412

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• AMIStem-P 01.18.415

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  2 reports
• AMIStem-P 01.18.399

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report

Recent AMIStem-P adverse event reports

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

• InjuryMay 22, 2026Fracture

  THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERIPROSTHETIC FRACTURE RESULTING IN A SUCCESSIVE STEM SUBSIDENCE BUT THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. AT 21 DAYS POST PRIMARY THE SURGEON CABLED THE FRACTURE AND REVISED THE AMISTEM-P SIZE 3 TO A DISTAL STEM D 13MM L 140MM AND REVISED THE BIOLOX 36MM HEAD S TO A BIOLOX 36MM HEAD M. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25253490 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY DUE TO STEM LOOSENING CAUSED BY INFECTION. THE SURGEON REVISED THE STEM AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25242298 ↗
• InjuryApr 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO STEM LOOSENING ABOUT 2 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Aseptic loosening

  MAUDE report 24776967 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AFTER 1 YEAR AND 2 MONTHS FROM PRIMARY DUE TO PERIPROSTHETIC INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 24711035 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT TWO WEEKS FROM THE PRIMARY SURGERY, THE PATIENTCAME IN FROM PAIN DUE TO A DISTAL FRACTURE OF THE FEMUR. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24674592 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 21 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE AMISTEM P STEM TO AN M-VIZION STEM WITH PROXIMAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24454904 ↗
• InjuryFeb 12, 2026Fracture

  AT6 YEARS 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN AS A RESULT OF A FALL. HE FELL ON HIS LEFT SIDEAND HEARD A POP IN THE RIGHT HIP. THE SURGEON OBSERVED THE X-RAYS, WHICH REVEALED THAT THE AMISTEM-P STEM HAD BROKEN. NO PREVIOUS REVISION SURGERY HAS BEEN PERFORMED. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND THE MEDACTA LINER TO A LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DESCRIBED AS VERY PHYSICALLY ACTIVE, WITH A ROBUST AND MUSCULAR BUILD.

  Patient problems: Implant Pain

  MAUDE report 24321109 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AT THE LESSER TROCHANTER AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE AMISTEM-P SIZE 3 STEM TO AN AMISTEM-C SIZE 5 STEM, AND REVISED THE HEAD TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24276570 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN THAT WAS THE RESULT OF A PERIPROSTHETIC FRACTURE. THE SURGEON CABLED THE FRACTURE, AND REVISED THE STEM TO A M-VIZION STEM AND THE HEAD TO AN IDENTICAL ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23886577 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A BONE BROKEN FEMUR DISTAL TO THE MEDACTA STEM. THE PATIENT DID NOT REPORT ANY TRAUMA. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23858468 ↗
• InjuryDec 10, 2025Implant subsidence; Implant subsidence

  THE PATIENT HAD PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23768145 ↗
• InjuryNov 28, 2025Fracture; Fracture

  REVISION SURGERY PERFORMED ABOUT 3 YEARS AFTER THE PRIMARY SURGERY DUE TO STEM NECK BREAKAGE WHILE THE PATIENT WAS GETTING OUT OF THE CAR. ON THE SAME DAY OF THE PRIMARY SURGERY, THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM TO STABILIZE THE JOINT. CERAMIC HEAD SIZE M WAS REMOVED AND BIOLOX OPTION AND XL SLEEVE WERE IMPLANTED TO STABILIZE THE JOINT.

  Patient problems: Insufficient Information

  MAUDE report 23669496 ↗
• InjuryNov 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA IMPLANTS AND PUT IN COMPETITOR SPACERS WITH ANTIBIOTIC CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23669494 ↗
• InjuryNov 5, 2025Loss of Osseointegration; Loss of Osseointegration

  AFTER 1 YEAR AND 4 MONTHS, THE PATIENT PRESENTED WITH PAIN RELATED TO A LOOSE STEM, AND THE CAUSE IS UNKNOWN. THE SURGEON DIAGNOSED THE STEM AS BEING “ POTTED, & RDQUO; MEANING IT WAS DISTALLY FIXED BUT LOOSE PROXIMALLY, CREATING A “ WINDSHIELD WIPER” EFFECT. THE SURGEON REVISED THE STEM USING A COMPETITOR IMPLANT AND ALSO REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23477170 ↗
• InjuryOct 29, 2025Implant subsidence; Implant subsidence

  THE PATIENT HAD PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON DETERMINED THAT THE EXISTING STEM HAD SUBSIDED CAUSING THE PAIN. THE SURGEON POINTED TO OLDER BONE EXPANDING AS CAUSE. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON REVISED THE HEAD AND REVISED THE STEM FROM A SIZE 4 TO A SIZE 7. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23412668 ↗

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