AMIStem C Femoral Stems 01.18.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030803802), received between Jan 16, 2019 and May 27, 2026 — classified as 3 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K103189); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 3 YEARS AND 11 MONTHS FROM THE PRIMAR, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED ALL MEDACTA IMPLANTS TO COMPETITOR IMPLANTS. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 25297685 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 WEEK AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PROXIMAL FEMORAL BONE FRACTURE, IN PARTICULAR THE X-RAYS SHOW A FRACTURE OF THE MEDIAL CALCAR THAT EXTENDS INFERIORLY 3 CM FROM THE LESSER TROCHANTER. IT HAS BEEN REPORTED THAT THE PATIENT WAS MOVING HER LEG IN A CHAIR AND HEARD A LOUD POP FOLLOWED BY PAIN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21968606 ↗
• InjuryDec 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE PRIMARY SURGERY WAS ON (B)(6) 2023 AND THE LINER HEAD AND STEM THAT WERE SUBSTITUTED ON (B)(6) 2024 DUE TO SIGNS OF AN INFECTION. ON (B)(6) 2024, AT ABOUT 11 MONTHS FROM THE PRECEDENT REVISION SURGERY FOR INFECTION THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20817092 ↗
• MalfunctionJan 16, 2019Tear, Rip or Hole in Device Packaging

  DURING SURGERY, IT WAS NOTICED THAT THE SECOND BLISTER WAS BROKE (PRIMARY PACKAGING). THE SURGEON DECIDED TO USE ANOTHER STEM TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252594 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103189. One submission often covers many models, so check the product and lot details in each record.

• Z-0791-2013 · Dec 17, 2012 · Terminated
  Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur