AMIStem C Femoral Stems 01.18.150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030804250), received between Sep 13, 2017 and Aug 27, 2025 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR A TOTAL RIGHT HIP REPLACEMENT. THE OPERATION WENT WELL, AND THE AFTER-EFFECTS WERE GOOD. ON (B)(6) 2013, THE PATIENT HAD A STEM REPLACEMENT FOLLOWING A TRAUMATIC LOOSENING. IN MAY 2025, THE PATIENT CAME IN DUE TO INCREASING PAIN. X-RAY IMAGING REVEALED ACETABULAR LOOSENING, LEADING TO THE INDICATION FOR REVISION OF THE ENTIRE HIP PROSTHESIS. ACCORDING TO THE SURGEON, THE CUP HAD BEEN MALPOSITIONED DURING THE PRIMARY PROCEDURE. INTRAOPERATIVELY, STEM DAMAGE AND INITIAL MIGRATION WERE OBSERVED, CAUSED BY STEM-CUP IMPINGEMENT DUE TO THE EXCESSIVELY ANTERIOR POSITION OF THE ACETABULAR COMPONENT. ON (B)(6) 2025 BOTH CUP AND STEM WERE REVISED. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22902791 ↗
• InjuryJul 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD AND COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19749120 ↗
• InjuryJan 8, 2024Migration; Migration

  AT ABOUT 7 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF CEMENTED STEM SUBSIDENCE. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 18464995 ↗
• InjuryNov 26, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 5 YEARS AND 2 MONTHS AFTER PRIMARY DUE TO STEM LOOSENING. STEM, PLUG, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 12878012 ↗
• InjuryNov 7, 2021Fracture

  WHEN INSERTING THE STEM, THE SURGEON NOTICED A FRACTURE AROUND THE STEM. HE WRAPPED THE CABLE AROUND THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THE CAUSE MAY BE OVER-INSERTION OF STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 12758266 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem

  ABOUT 4 MONTHS AFTER PRIMARY THE PATIENT TWISTED HER LEG AT HOME CAUSING A PERI PROSTHETIC FEMUR FRACTURE. THE SURGEON REVISED SUCCESSFULLY THE PATIENT STEM.

  Patient problems: Hip Fracture

  MAUDE report 9568224 ↗
• InjuryDec 2, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PER-OPERATIVE PERI-PROSTETIC FRACTURE FIXED WITH A SCREW DURING THE PRIMARY SURGERY. THE PATIENT HAD A FRACTURE 3 WEEK POST-OPERATION AND WAS REVISED ABOUT 1 MONTH POST PRIMARY. STEM AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 9393428 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 11 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR HIP INFECTION. STEM, HEAD, CUP AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8150505 ↗
• InjurySep 13, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE PATIENT WAS ALSO INFECTED. THE INFECTION IS NOT BELIEVED TO HAVE CAUSED THE LOOSENING. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA PRODUCT. THE SURGEON PLANS TO IMPLANT A SPACER AT A LATER DATE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 6860918 ↗

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