AMIStem-P Collared 01.18.431Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630040720205), received between Jul 31, 2020 and Oct 29, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE SURGEON NEEDED A DRAINAGE AT THE INCISION SITE 2 WEEKS POST-OP FOR INFECTION. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23411609 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO A PERIPROSTHETIC FEMUR FRACTURE AND THE CAUSE IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20493575 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING PRIMARY HIP SURGERY, AFTER BROACHING, WHEN THE SURGEON PUT THE STEM HE NOTICED IT WAS TOO LONG SO HE REMOVED IT AND PUT A SMALLER STEM IN. WHEN TAKING A POST-OP X-RAY, IT WAS OBSERVED THAT THE FEMUR WAS FRACTURED. AT ABOUT 10 DAYS AFTER THE PRIMARY, THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THE FRACTURE OCCURRED DURING THE BROACHING OR DURING THE INSERTION OF THE FIRST STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 19132099 ↗
• InjuryFeb 14, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18702081 ↗
• InjuryMay 31, 2023Migration; Migration

  ABOUT 2 MONTHS AFTER THE SURGERY, THE PATIENT COMPLAINED OF PAIN, AND WHEN AN X-RAY WAS TAKEN, IT WAS DISCOVERED THAT THE STEM WAS SINKING. THE PATIENT IS UNDER MONITORING AND THE SURGEON IS EVALUATING A REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 17030861 ↗
• InjuryMay 31, 2022Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY AT 6 MONTHS FROM PRIMARY FOR STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

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

  MAUDE report 14547227 ↗
• InjuryMay 6, 2022Osseointegration Problem; Osseointegration Problem

  AT 2 YEARS 10 MONTHS AFTER 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: Pain

  MAUDE report 14300696 ↗
• InjuryMar 23, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 MONTH FROM PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED A SPACER. THE PATHOGEN IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13860768 ↗
• InjuryJun 1, 2021Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. 3 DAYS AFTER PRIMARY THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11911476 ↗
• InjuryJul 31, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON 18 JUNE 2020, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, 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 10349975 ↗