AMIStem-P 01.18.401Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630040720007), received between May 22, 2019 and Dec 24, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 19, 2024Osseointegration Problem; Osseointegration Problem

  HIP REVISION DUE TO STEM LOOSENING. THE HEAD AND STEM HAVE BEEN REVISED SUCCESSFULLY. PRIMARY SURGERY DATE IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 19566893 ↗
• InjuryJul 31, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17424478 ↗
• InjuryJan 19, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16204987 ↗
• InjuryJun 9, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE STEM AND THE CAUSE IS UNKNOWN. AT 3 YEARS AND 5 MONTHS FROM PRIMARY THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14643331 ↗
• InjuryNov 17, 2021Appropriate Device Problem Term/Code Not Available

  AT 4 MONTHS AFTER PRIMARY THA, REVISION SURGERY FOR STEM SUBSIDENCE. THE REASON OF THE SUBSIDENCE IS UNKNOWN. STEM AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12826689 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY REPORTING PAIN DUE TO FALLING. THE SURGEON OBSERVED REDNESS AND SWELLING AT THE INCISION SITE AND DECIDED TO PERFORM A WASHOUT AND REVISE THE HEAD AND LINER. 1 DAY AFTER THE REVISION THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11676929 ↗
• InjuryFeb 18, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE 3 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE PERIPROSTHETIC FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE, REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11341873 ↗
• InjuryDec 29, 2020Migration or Expulsion of Device

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM, 1 YEAR 4 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE AMISTEM-P STD. #1 WITH A SMS SOLID STEM STD #10 AND REVISED THE 32MM BIOLOX DELTA HEAD S WITH A 32MM BIOLOX DELTA HEAD S.

  Patient problems: Pain

  MAUDE report 11086056 ↗
• InjuryMar 4, 2020Fracture

  THE PATIENT CAME IN REPORTING PAIN DUE TO A BONE FRACTURE AFTER 1 MONTH AND HALF FROM THE PRIMARY. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9785156 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem

  DURING THE PRIMARY HIP SURGERY AND UPON THE SURGEON IMPLANTING THE STEM, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE OF THE FEMUR, PRIMARY SURGERY WAS PERFORMED USING POSTERIOR APPROACH. THE SURGEON CABLED THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FEW DELAY OF 4 MINUTES. THE PATIENT WAS OBESE AND SMOKER.

  Patient problems: Bone Fracture(s)

  MAUDE report 8631625 ↗