AMIStem-P Collared 01.18.436Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040720250), received between May 20, 2020 and Jan 10, 2024 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 4 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18482446 ↗
• InjuryMay 3, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. AT 9 MONTHS POST PRIMARY THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14267101 ↗
• InjuryJul 2, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING THIGH PAIN DUE TO A SUBSIDED STEM. THE SURGEON 6 MONTHS AFTER PRIMARY REVISED THE STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10224643 ↗
• InjuryJul 2, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE SURGEON REVISED THE CUP, BALL HEAD, AND LINER DUE TO THE MOBILIZATION WHICH CAUSED THE MALPOSITIONING OF THE CUP AFTER 9 MONTHS FROM THE PRIMARY SURGERY. DURING THE PRIMARY SURGERY THE CUP WAS IN THE CORRECT POSITION.

  Patient problems: No Code Available

  MAUDE report 10224640 ↗
• InjuryMay 20, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 10 MONTHS AFTER PRIMARY SURGERY, DUE TO AN INFECTION AT THE FEMORAL PART ( PATHOGEN AGENT UNKNOWN ). THE SURGEON REMOVED THE WHOLE PROSTHESIS WITHOUT DIFFICULTY. THE INFECTION WAS IMPORTANT SO THE SURGEON DECIDED TO NOT PLACED NEW IMPLANTS AND USED A SPACER INSTEAD.

  Patient problems: Unspecified Infection

  MAUDE report 10073716 ↗