AMIStem-P 01.18.414Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630040720137), received between May 8, 2019 and Feb 26, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 21 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE AMISTEM P STEM TO AN M-VIZION STEM WITH PROXIMAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24454904 ↗
• InjuryJun 22, 2023Migration; Migration

  REVISION SURGERY PERFORMED DUE TO SUBSIDED STEM, AT ABOUT 1 YEAR AFTER THE PRIMARY. THE PATIENT REPORTED PAIN AND THE X-RAYS REVEALED THAT THE STEM WAS UNDERSIZED. THE SURGEON REVISED ALSO THE CUP THAT APPEARED LOOSENED.

  Patient problems: Implant Pain

  MAUDE report 17181541 ↗
• InjuryFeb 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2022, 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. PRESENTLY, ON (B)(6) 2023, HE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16321172 ↗
• InjuryDec 22, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 14 DAYS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A FRACTURED ACETABULUM, AND DUE TO SIGNS OF AN INFECTION. THE CAUSE OF THE FRACTURE IS UNKNOWN, AND THE PATHOGEN IS UNKNOWN FOR THE INFECTION. THE SURGEON PERFORMED A WASHOUT FOR THE INFECTION AND CABLED AND PLATED THE FRACTURE, AND REVISED THE LINER, STEM, CUP, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 11053922 ↗
• InjuryJul 29, 2019Fracture; Appropriate Device Problem Term/Code Not Available

  7 MONTHS AFTER PRIMARY THE PATIENT HAD A REVISION SURGERY DUE TO STEM MOBILIZATION. THE STEM AND HEAD HAVE BEEN REPLACED SUCCESSFULLY. DURING THE PRIMARY SURGERY PERFORMED IN (B)(6) 2018 THE SURGEON HAD A PER-OPERATIVE GREAT TROCHANTER FRACTURE, TREATED WITH CERCLAGE. NOBODY OF MEDACTA WAS AWARE OF THE FRACTURE TILL THIS COMPLAINT NOTIFICATION.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 8835297 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem

  DURING FINAL IMPLANT INSERTION THE STEM SUNK 4MM AND A SMALL DISTAL FISSURE WAS DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY IMPLANTING A COMPETITOR STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 8591156 ↗