AMIStem-P Short Neck 01.18.462Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630971243668), received between Jan 26, 2022 and May 27, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 WEEKS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND A PERIPROSTHETIC BONE FRACTURE WAS CONFIRMED. THE SURGEON REVISED SUCCESSFULLY THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 22087872 ↗
• InjuryJun 20, 2024Migration; Migration

  HIP REVISION DUE TO PERIPROSTHETIC FRACTURE THAT WAS CAUSED BY STEM SUBSIDENCE AT 21 DAYS FROM PRIMARY SURGERY. THE STEM IMPLANTED WAS UNDERSIZED. PATIENT'S BONE QUALITY WEAK. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 19573046 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABOUT 10 DAYS AFTER THE PRIMARY SURGERY, IT WAS CONFIRMED A POSTERIOR FRACTURE OF THE FEMUR. A SECOND SURGERY WAS PERFORMED AND THE FEMUR WAS FIXED WITH A WIRE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON THINKS THE CAUSE MAY BE THE LOAD ON THE FEMUR DUE TO RASPING OR OVERSIZE OF THE IMPLANT; THERE WAS NO SUBSIDENCE, SO IT MAY HAVE BEEN FRACTURED DURING THE SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16467462 ↗
• InjuryMay 3, 2022Positioning Problem

  AT 1 MONTH AFTER THE PRIMARY SURGERY, DURING A FOLLOW-UP VISIT, STEM SINKING ASSOCIATED WITH PERI-STEM FRACTURES IS OBSERVED. HOWEVER, THERE WERE NO COMPLAINTS FROM THE PATIENT SUCH AS PAIN, AND SHE WAS ABLE TO WALK WITHOUT PROBLEMS. THE PATIENT REJECT THE REVISION SURGERY, BUT THE SURGEON WILL CONTINUE TO RECOMMEND REVISION SURGERY. FRACTURE LINES MAY BE SEEN ON X-RAYS POST-PRIMARY. IT IS UNCLEAR WHETHER THE OPERATION OF THE RASPS DURING THE SURGERY WAS BAD, BUT IT MAY BE DUE TO THE FACT THAT THE RASPS WERE TAKEN IN AND OUT MANY TIMES DURING THE SURGERY DUE TO UNFAMILIAR SURGERY. BONE QUALITY IS UNKNOWN.

  Patient problems: Hip Fracture

  MAUDE report 14267059 ↗
• InjuryJan 26, 2022Fracture; Improper or Incorrect Procedure or Method

  DURING THE PRIMARY HIP SURGERY, THE PATIENT SUSTAINED AN INTRAOPERATIVE FEMORAL FRACTURE. THE SURGEON FIXED WITH THE 2 CABLES AND EXPRESSED AN OPINION THAT THE EVENT WAS CAUSED BY A TECHNICAL ERROR. NO FAILURE SEEMED TO BE OBSERVED ON DEVICE.

  Patient problems: Bone Fracture(s)

  MAUDE report 13356858 ↗