AMIStem H Femoral Stems 01.18.147Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030804236), received between Feb 16, 2018 and Sep 9, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093944, K250450); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Osseointegration Problem

  Revision surgery due to Amistem H loosening. Multiple tests for infection were performed, all of which were negative. The stem was easily removed manually by the surgeons, without the need for any extraction devices. A cemented competitor`s stem was successfully implanted.

  Patient problems: Aseptic loosening

  MAUDE report 50692324 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PERIPROSTHETIC FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. AT ABOUT 10 YEARS AND 3 MONTHS POST PRIMARY, THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23036834 ↗
• InjuryFeb 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO STEM LOOSENING, STEM AND HEAD REVISED. PRIMARY WAS PERFORMED IN (B)(6) 2012. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 9726276 ↗
• InjuryJun 5, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 8 MONTHS AFTER THE PRIMARY DUE TO THE MOBILIZED STEM. THE STEM AND BALL HEAD HAVE BEEN REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8669901 ↗
• InjuryJun 22, 2018Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  WE WERE INFORMED ON (B)(6) 2018 THAT A PATIENT CAME IN COMPLAINING OF PAIN AND TROUBLE WALKING. THE STEM MAY HAVE SUBSIDED. THE SURGEON PLANS TO TRY A LONGER HEAD, THEN EXCHANGE STEM IF THAT DOES NOT WORK. ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON IMPLANTED A LONGER HEAD AND AS THE STEM SUBSIDED AND SETTLED IT RETROVERTED A BIT MORE. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7629555 ↗
• InjuryFeb 16, 2018Fracture

  DURING THE STEM POSITIONING AN INTERTROCHANTERIC FRACTURE WAS GENERATED. THE SURGEON COMPLETED SUCCESSFULLY THE SURGERY PERFORMING INTRAOPERATIVELY A BONE CERCLAGE.

  Patient problems: Hip Fracture

  MAUDE report 7276208 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093944, K250450. 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