AMIStem-P 01.18.404Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630040720038), received between Feb 13, 2019 and Dec 10, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Fracture” (3 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMay 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 WEEKS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF PROXIMAL FEMORAL BONE FRACTURE, FOLLOWING INAPPROPRIATE WORK WITH THE PHYSIOTHERAPIST. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21974578 ↗
• InjuryFeb 20, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 10 MONTHS AFTER 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 21418876 ↗
• InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS REPORTED TO BE AN UNDERSIZED STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH MEDACTA COMPONENTS AND REVISED THE MEDACTA LINER AND CUP WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 21354288 ↗
• InjurySep 13, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 4 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Implant Pain

  MAUDE report 17734748 ↗
• InjuryMar 11, 2022Appropriate Device Problem Term/Code Not Available

  AT 14 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AFTER TWISTING THE LEG AND BREAKING THE FEMUR JUST BELOW THE TIP OF THE STEM. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 13732016 ↗
• InjuryJun 16, 2021Fracture

  2 WEEKS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A PERI-PROSTHETIC FRACTURE OF THE FEMUR AND THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGEON CABLED THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 12007037 ↗
• InjuryDec 30, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY, DUE TO A BROKEN FEMUR. STEM, BALL HEAD AND BIPOLAR HEAD HAVE BEEN SUCCESSFULLY REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11093712 ↗
• InjuryDec 21, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOR HIP INFECTION 3 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11045448 ↗
• InjurySep 22, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 2 MONTHS AFTER PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND DID NOT REVISE ANY COMPONENTS.THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10567152 ↗
• InjuryMay 8, 2020Fracture

  THE PATIENT CAME IN REPORTING PAIN DUE TO A FEMUR PERIPROSTHETIC FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10037454 ↗
• InjuryNov 11, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED AFTER 6 DAYS FROM THE PRIMARY DUE TO STEM SUBSIDENCE CAUSED BY A FEMUR FRACTURE. PRIMARY SURGERY: THE SURGEON REVISED ALL IMPLANTS AND PLACED A STRAPPING ON THE FEMUR.

  Patient problems: Bone Fracture(s)

  MAUDE report 9304031 ↗
• InjuryNov 6, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER ALMOST 1 YEAR AND 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9283659 ↗
• InjuryApr 18, 2019Fracture

  REVISION SURGERY AFTER 32 DAYS FROM THE PRIMARY DUE TO PAIN CAUSED BY FRACTURED FEMUR (THE CAUSE OF THE FRACTURE IS UNKNOWN). THE SURGEON CABLED THE FRACTURE, REVISED THE HEAD AND STEM WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8527552 ↗
• InjuryFeb 13, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR STEM SUBSIDENCE. STEM REVISED SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 8335140 ↗