AMIStem C Femoral Stems 01.18.151Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030804267), received between Oct 6, 2017 and Oct 15, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A POSTOPERATIVE FOLLOW-UP EXAMINATION, X-RAY IMAGING REVEALED CORTICAL HYPERTROPHY AT THE DISTAL PORTION OF THE STEM (RIGHT SIDE). THE PATIENT REMAINS UNDER OBSERVATION. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019 (RIGHT SIDE), (B)(6) 2019 (LEFT SIDE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289777 ↗
• InjuryAug 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION AT ABOUT 9 YEARS AND 8 MONTHS FROM THE PRIMARY SURGERY DUE TO STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 22922930 ↗
• InjuryMar 31, 2023Migration; Migration

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE CEMENTED STEM HAD SUBSIDED SLIGHTLY LEAVING THE PATIENT UNSTABLE. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON DECIDED TO REVISE THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16655502 ↗
• InjuryFeb 24, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16435568 ↗
• InjuryJul 9, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. 5 YEARS AND 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR IMPLANTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12141632 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem

  AFTER THE INSERTION OF THE STEM, FEMORAL PERFORATION WAS CONFIRMED ON THE FINAL CHECKING X-RAY. THE SURGEON DECIDED TO FINISH THE SURGERY WITHOUT ANY TREATMENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 12015241 ↗
• InjuryNov 12, 2019Fracture

  PER OPERATIVE FRACTURE OF THE TROCHANTERIAN MASSIF WHILE USING THE GRATERS. THE SURGEON DECIDED TO DON'T REVISE ANY IMPLANTS AND USE STRAPPING FOR THE FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9308987 ↗
• InjuryFeb 23, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 THE SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT A REVISION SURGERY WAS PERFORMED. AT THIS TIME WE DO NOT KNOW IF THE REASON OF THE REVISION SURGERY IS BONE FRACTURE OR STEM LOOSENING.

  Patient problems: Bone Fracture(s)

  MAUDE report 7291629 ↗
• InjuryFeb 23, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 THE SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT A REVISION SURGERY WAS PERFORMED. AT THIS TIME WE DO NOT KNOW IF THE REASON OF THE REVISION SURGERY IS BONE FRACTURE OR STEM LOOSENING.

  Patient problems: No Code Available

  MAUDE report 7291618 ↗
• InjuryOct 6, 2017Device Slipped; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON REVISED THE STEM ONLY AND RE-IMPLANTED A SIZE 0 STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 6921409 ↗

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