AMIStem-P Collared 01.18.438Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040720274), received between Aug 5, 2020 and Sep 12, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15400680 ↗
• InjuryMay 10, 2021Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Insufficient Information

  MAUDE report 11795931 ↗
• InjuryAug 5, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE; THE CAUSE OF THE PERIPROSTHETIC FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10366566 ↗