AMIStem-P 01.18.400Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630040719995), received between Nov 11, 2019 and Aug 27, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 YEARS AND 1 MONTH FROM PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 22901810 ↗
• InjuryJul 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17376772 ↗
• InjuryMay 19, 2023Fracture; Fracture

  REVISION SURGERY PERFORMED DUE TO STEM BREAKAGE, ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY.

  Patient problems: Insufficient Information

  MAUDE report 16961115 ↗
• InjuryNov 22, 2021Osseointegration Problem; Osseointegration Problem

  AT 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, 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 AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12851093 ↗
• InjuryMay 19, 2021Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  11 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT HAD A 1.5CM TOO LONG LEG, THEREFORE THE SURGEON DECIDED TO REMOVE THE STEM AND TO PUT A NEW ONE, TRYING TO SHORTEN THE LEG.

  Patient problems: Insufficient Information

  MAUDE report 11848921 ↗
• InjurySep 28, 2020Loose or Intermittent Connection; Microbial Contamination of Device

  THE PATIENT WAS PRIMARLY OPERATED ON (B)(6) 2019. AFTER THIS FIRST SURGERY SHE HAD AN INFECT OF THE WOUND WHICH HEALED. HOWEVER SINCE THE SURGERY SHE ALWAYS HAD PAIN AND DIFFICULTIES IN WALKING.THEREFORE 9 MONTHS AFTER PRIMARY THE HIP WAS REVISED AND EVERYTHING WAS REMOVED. THE STEM WAS LOOSE. NOTHING NEW WAS IMPLANTED, SINCE ALSO BACTERIOLOGICAL TESTS WERE DONE TO SEE IF THERE IS A POSSIBLE INFECT. NOTHING HAS BEEN IDENTIFIED BY BACTERIOLOGICAL TESTS AND THE STAPHYLOCOCCUS ON THE STEM IS LIKELY DUE TO SOME CONTAMINATION, SO THE LOOSENING IS NOT DUE TO AN INFECTION. ON THE (B)(6) 2020 A VERSACEM 56 WITH A 28XL HEAD (COCR) AND A 2STD P AMISTEM WERE IMPLANTED. THE OPERATION WENT WELL.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 10593613 ↗
• InjuryNov 11, 2019Appropriate Device Problem Term/Code Not Available

  BONE FRACTURE THAT CAUSED A SUBSIDENCE OF THE STEM. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM 1 MONTH AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9304130 ↗