AMIStem-P CollaredRecalls & reported problems across all models

We found 18 models of AMIStem-P Collared by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Apr 3, 2019 and Sep 9, 2026 — classified as 99 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (25 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 Collared problems

AMIStem-P Collared models

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

• AMIStem-P Collared 01.18.432

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  19 reports
• AMIStem-P Collared 01.18.434

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  14 reports
• AMIStem-P Collared 01.18.433

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  13 reports
• AMIStem-P Collared 01.18.431

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  10 reports
• AMIStem-P Collared 01.18.435

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  7 reports
• AMIStem-P Collared 01.18.442

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  6 reports
• AMIStem-P Collared 01.18.436

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  5 reports
• AMIStem-P Collared 01.18.437

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  4 reports
• AMIStem-P Collared 01.18.438

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• AMIStem-P Collared 01.18.440

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• AMIStem-P Collared 01.18.444

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• AMIStem-P Collared 01.18.445

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  3 reports
• AMIStem-P Collared 01.18.430

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  2 reports
• AMIStem-P Collared 01.18.441

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  2 reports
• AMIStem-P Collared 01.18.443

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  2 reports
• AMIStem-P Collared 01.18.429

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report
• AMIStem-P Collared 01.18.447

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  1 report
• AMIStem-P Collared 01.18.448

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

Recent AMIStem-P Collared 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 after 1 year and 2 months due to stem loosening that caused pain and instability.The surgeon revised the Amistem-P Collared size3 to a SMS Collared Solid Stem LAT size11and revised the 36mm Biolox Head M to a 36mm BIOLOX Delta Head L. The surgery was completed successfully.

  Patient problems: Aseptic loosening

  MAUDE report 50692313 ↗
• InjurySep 9, 2026Osseointegration Problem

  At about 7 months from the primary, the patient came in presenting pain and instability 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 Flat PE HC liner D 36/E to a same size liner. The surgery was completed successfully.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 50692306 ↗
• InjuryJul 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO TITANIUM ALLERGY AFTER ABOUT 9 MONTHS AFTER PRIMARY. THE SURGEON REMOVED ALL EXISTING IMPLANTS, CEMENTED A HOODED PE HC LINER D 36/E AND QUADRA-P CEMENTED LAT. SIZE 1 AND REVISED THE 32MM BIOLOX DELTA HEAD S TO A 36MM BIOLOX DELTA HEAD M. THE PATIENT HAD A FRACTURE SO THE TITANIUM CABLES WERE REPLACED WITH MBRACE CABLES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Implant Pain; Metal Related Pathology

  MAUDE report 25763497 ↗
• InjuryJul 9, 2026Implant subsidence

  AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR BONE QUALITY ISSUES. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DME TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25763459 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 WEEK FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA.THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR DEVICES AND REPLACED THE DOUBLE MOBILITY LINER WITH A LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25714736 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE AMISTEM-P SIZE4 TO AN AMISTEM-P SIZE5, REVISED THE D 28/DMH LINER TO A D 28/DMI LINER, REVISED THE 28MM BIOLOX HEAD S TO A SAME SIZE HEAD, AND REVISED THE MPACT DM D 56 CUP TO A MPACT DM D 58 CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25442544 ↗
• InjuryMay 27, 2026Fracture

  REVISION SURGERY DUE A PERIPROSTHETIC BONE FRACTURE BELOW THE STEM AFTER 18 DAYS FROM PRIMARY. THE SURGEON REVISED ALL MEDACTA IMPLANTS (STEM, HEAD, LINER, SHELL) TO COMPETITOR IMPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 25297696 ↗
• InjuryApr 28, 2026Osseointegration Problem

  AT ABOUT 9 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 MADE NO NOTE OF BONE QUALITY. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND REVISED THE MEDACTA D 40 FLAT LINER TO A D 28 DOUBLE MOBILITY LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25012263 ↗
• InjuryApr 28, 2026Osseointegration Problem

  AT ABOUT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATIONS OF A FALL OR TRAUMA. THE SURGEON 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 25012251 ↗
• InjuryMar 30, 2026Osseointegration Problem

  AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE AMISTEM-P SIZE 2 STEM TO A SIZE 3 AND REVISED THE 40 MM BIOLOX HEAD TO A SAME SIZE BIOLOX HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED TRAUMA.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24710798 ↗
• InjuryJan 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY WAS PERFORMED 1 YEAR AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION; THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24020867 ↗
• InjuryDec 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAS A PRIMARY HIP SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE LINER, HEAD AND CUP (MDR 2025-01040). PRESENTLY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA STEM AND HEAD WITH ANOTHER MEDACTA STEM AND HEAD AND REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR`S PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23858475 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT1 YEAR 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM AND REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23837340 ↗
• InjuryDec 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO A HEMATOGENOUS INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON SWAPPED THE LINER HEAD AND STEM AND REVISED THE CUP FROM A DUAL MOBILITY TO A STANDARD CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23690778 ↗
• InjuryOct 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE SURGEON NEEDED A DRAINAGE AT THE INCISION SITE 2 WEEKS POST-OP FOR INFECTION. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23411609 ↗

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