AMIStem H Collared Femoral Stems 01.18.233Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030804588), received between Oct 31, 2017 and Jan 16, 2025 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Osseointegration Problem; Osseointegration Problem

  PRIMARY SURGERY ON (B)(6) 2016, PATIENT FALL ON 2022, PAIN WORSENED ON (B)(6) 2024. ON RADIOGRAPHY STEM LOOSENING AND SUBSIDENCE CONFIRMED. ON (B)(6) 2024, ABOUT 8 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 21168800 ↗
• InjuryMar 27, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT 8 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISTALLY POTTED 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 18984914 ↗
• InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 8 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18516285 ↗
• InjuryOct 13, 2023Migration; Migration

  AT ABOUT 5 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17929342 ↗
• InjuryAug 31, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT ABOUT 2 MONTHS POST PRIMARY FOR STEM POTTING. THE STEM POTTING REASON IS UNKNOWN. STEM, HEAD, AND LINER REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15326886 ↗
• InjuryJan 31, 2022Osseointegration Problem; Osseointegration Problem

  AT 7 YEARS AND 1 MONTH FROM PRIMARY, THE SURGEON PERFORMED A REVISION SURGERY FOR STEM LOOSENING. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13392086 ↗
• InjuryNov 11, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN, THE CAUSE OF THE PAIN IS UNKNOWN, 2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REMOVED ALL REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10822489 ↗
• InjuryJul 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 1 YEAR AND 10 MONTHS AFTER PRIMARY SURGERY FOR STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 10239483 ↗
• InjuryOct 9, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 1 MONTH AFTER THE PRIMARY DUE TO PAIN. AFTER EXAMINING X-RAY, THE SURGEON DETERMINED IT WAS MOST LIKELY A LOOSE STEM SO HE DECIDED TO REVISE. THE STEM AND THE HEAD HAVE BEEN REVISED. THE STEM MAY HAVE HAD MICRO MOVEMENT BUT WAS STILL FIXED FIRMLY DISTALLY AND IT WAS REMOVED WITH GREAT DIFFICULTY.

  Patient problems: Joint Disorder

  MAUDE report 9171455 ↗
• InjuryJul 25, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 10 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY MOBILIZED STEM. THE STEM MOBILIZATION CAUSED INSTABILITY WHAT CAUSED THAT THE PATIENT FALL AND FRACTURED THE FEMUR. THE STEM HAS BEEN REVISED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8825503 ↗
• InjuryDec 18, 2018Fracture

  AFTER THE SURGERY THE SURGEON DETECTED A DISTAL FEMUR FRACTURE. THE SAME DAY THE PATIENT WAS REOPERATED AND THE STEM WAS REPLACED SUCCESSFULLY USING A COMPETITOR DEVICE; THE FEMUR WAS CABLED. THE PRIMARY SURGERY HAD BEEN NORMALLY CARRIED OUT UNTIL THE USE OF SIZE 3 BROACH, WHICH STOOD PROUD; THE SURGEON DECIDED TO USE FLEXIBLE REAMERS THEN BROACH 2 THEN BROACH 3 UNTIL THE CALCAR OF THE FEMUR SIZE WAS REACHED. AT THIS STAGE HE PERFORMED AN RX AND EVERYTHING WAS OK, WITHOUT ANY SIGN OF FRACTURE AND THE CHOICE OF IMPLANTS WAS DONE (AMISTEM-H STD 3 COLLARED). WHEN IMPLANTING THE PROSTHESIS NOTHING ABNORMAL HAPPENED AND DURING THE REDUCTION EVERYTHING WENT WELL. ONLY AT THE END OF THE RX CONTROL POST-OPERATION THE DISTAL SLIT APPEARED.

  Patient problems: Bone Fracture(s)

  MAUDE report 8173612 ↗
• InjuryApr 26, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 7 MONTHS AFTER PRIMARY. THE PATIENT WAS (B)(6) FOR (B)(6). ALL IMPLANTS WERE REMOVED AND A SPACER WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7464053 ↗
• InjuryApr 6, 2018Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN TEN DAYS AFTER THE PRIMARY. THE STEM WAS LOOSE. THE SURGEON REVISED THE STEM, HEAD AND LINER SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7402532 ↗
• InjuryDec 15, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THAT THE STEM WAS LOOSE. THE STEM HAD SUBSIDED OVER TIME. NO TRAUMA WAS REPORTED.

  Patient problems: Joint Disorder

  MAUDE report 7120556 ↗
• InjuryOct 31, 2017Device Operates Differently Than Expected

  THE STEM HAD SUBSIDED. THE CAUSE OF THE STEM SUBSIDING IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6990608 ↗