AMIStem-H Proximal Coating Femoral Stems 01.18.174Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030804397), received between Dec 7, 2017 and Sep 9, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Revision surgery due to a periprosthetic fracture after about 9 years and 2 months from primary. The surgeon cabled the fracture and revised the Flat PE HC liner D 32/F to a Flat PE HC liner D 40/F at his discretion.

  Patient problems: Bone Fracture(s)

  MAUDE report 50692303 ↗
• InjuryAug 3, 2020Appropriate Device Problem Term/Code Not Available

  THE HIP OF THE PATIENT WAS REVISED ON THE (B)(6) 2020 (2 MONTHS AFTER PRIMARY) DUE TO THE LOOSENING OF THE HIP STEM. INITIALLY, HE WANTED TO CHANGE ONLY THE STEM, BUT SINCE THE SURGEON DID A PUNCTURE AND DISCOVERED A LOW-GRADE INFECTION, HE DECIDED ALSO TO CHANGE THE CUP AND THE LINER. NO MORE INFORMATION ABOUT THE INFECTION AGENT IS AVAILABLE. IT IS UNKNOWN IF THE LOOSENING IS RELATED TO THE INFECTION.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 10354963 ↗
• InjurySep 19, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE LINER AND THE STEM 1 YEAR 9 MONTHS AND 1 WEEK AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9086482 ↗
• InjuryJul 30, 2019Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth

  ON THE (B)(4) 2019 WE WERE INFORMED OF A REVISION SURGERY PERFORMED ON THE (B)(6) 2019, ABOUT 4 MONTHS AND A HALF FROM THE PRIMARY FOR STEM LOOSENING AND CUP MALPOSITIONING. FEMUR STRESS SHIELDING WAS DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8840207 ↗
• InjuryOct 26, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 9 DAYS AFTER PRIMARY DUE TO PROXIMAL FEMUR BONE FRACTURE. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND THE LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 8008972 ↗
• InjuryDec 7, 2017Fracture

  DURING STEM IMPLANTATION THE BONE FEMUR WAS FRACTURED, THE FRACTURE WAS TREATED WITH A CERCLAGE. THE AMISTEM-H PROXIMAL COATING WAS REPLACED WITH A CEMENTED STEM.

  Patient problems: Hip Fracture

  MAUDE report 7095271 ↗