AMIStem H Collared Femoral Stems 01.18.231Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030804564), received between Sep 13, 2017 and Dec 18, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 18, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23836919 ↗
• InjuryJun 13, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 10 YEARS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19527585 ↗
• InjuryDec 21, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 YEARS AND 4 MONTHS 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 MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18370902 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 3 MONTHS AFTER THE PRIMARY SURGERY, IT WAS DETECTED STEM LOOSENING. THE PATIENT FELT ABNORMAL FEELING. NO INFECTION REPORTED. THERE WAS NO PROBLEM AT THE TIME OF 1 YEAR AFTER THE PRIMARY SURGERY. AT THE BEGINNING THE REVISION SURGERY DID NOT SEEM NECESSARY, BUT EVENTUALLY THE STEM AND HEAD WERE REPLACED SUCCESSFULLY WITH COMPETITOR'S IMPLANTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15893452 ↗
• InjurySep 30, 2022Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Pain

  MAUDE report 15518382 ↗
• InjuryNov 22, 2021Fracture

  ABOUT 1 WEEK AFTER THE PRIMARY SURGERY, THE SURGEON NOTICED ON THE X-RAY THAT A GREATER TROCHANTERIC FRACTURE IS VISIBLE, AND PERFORMED OSTEOSYNTHESIS USING A PLATE AND WIRE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE FRACTURE IS UNKNOWN, BUT IT MAY HAVE OCCURRED DURING EXTERNAL ROTATION OF THE FEMUR OR WHEN USING A STARTER REAMER OR RASP. THE BONE QUALITY WAS NOT GOOD.

  Patient problems: Hip Fracture

  MAUDE report 12852043 ↗
• InjuryDec 12, 2018Fracture

  REVISION SURGERY PERFORMED DUE TO BONE FRACTURE 10 DAYS AFTER PRIMARY. THE PATIENT DIDN'T REPORT ABOUT ANY TRAUMA. ACCORDING TO THE SURGEON, THE FRACTURE COULD HAVE BEEN ORIGINATED BY THE IMPLANTED PROSTHESIS. THE SURGEON REVISED THE PATIENT ON (B)(6) 2018 WITH A CORAIL STEM END ZIMMER STRAPPING CABLES.

  Patient problems: Bone Fracture(s)

  MAUDE report 8155023 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT WAS POSITIVE FOR AN INFECTION. THE PATHOGEN WILL NOT BE DISCLOSED. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON 01 DECEMBER 2017 WE WERE INFORMED BY THE COMPLAINER THAT THE SECOND STEP OF THE SURGERY HAS BEEN COMPLETED. THE SURGEON REVISED THE ABX SPACER AND IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017.

  Patient problems: Unspecified Infection

  MAUDE report 6878304 ↗
• InjurySep 20, 2017Inadequacy of Device Shape and/or Size

  POST-OP THE SURGEON DETERMINED THE LEG LENGTH WAS OFF. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6878297 ↗
• InjurySep 13, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6860921 ↗
• InjurySep 13, 2017Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON REMOVED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6860920 ↗