AMIStem H Femoral Stems 01.18.146Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030804229), received between Nov 16, 2018 and Oct 7, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2024Migration; Migration

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. ABOUT 12 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 20383568 ↗
• InjurySep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 13 YEARS 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. ALL COMPONENTS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20155193 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PAIN DUE TO A DISTAL PERIPROSTHETIC FEMORAL FRACTURE (AT THE DISTAL TIP LEVEL) AND THE CAUSE IS UNKNOWN. AT 11 YEARS AND 2 MONTHS POST PRIAMRY THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM WITH A COMPETITOR STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19248899 ↗
• InjuryJul 26, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY ABOUT 9 YEARS AND 5 MONTHS AFTER PRIMARY DUE TO STEM LOOSENING. THE PRIMARY SURGERY EXACT DATE IS UNKNOWN, IT WAS IN 2012. SOME GRANULOMA FROM ABRASION WERE FOUND IN THE HIP, THE HIP SYSTEM HAD A METAL-ON-METAL BEARING FROM A COMPETITOR. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12223756 ↗
• InjuryMay 31, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION OF FEMORAL STEM DUE TO ASEPTIC LOOSENING 2 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY ON AN ACTIVE PATIENT THAT UNDERWENT OSTEOTOMIES OF THE FEMUR IN THE PAST DUE TO DYSPLASIA. THE STEM WAS FOUND GROSSLY LOOSE AND EXCHANGED TO QUADRA R. LINER WAS ALSO EXCHANGED TO CONVERTOR AND DUAL MOBILITY AS OF SURGEON PREFERENCE FOR THE REVISION CASE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11907143 ↗
• InjuryMay 12, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY 9 YEARS AND 8 MONTHS AFTER PRIMARY, FOR ASEPTIC LOOSENING OF THE STEM. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

  Patient problems: Insufficient Information

  MAUDE report 11812570 ↗
• InjuryJul 13, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 8 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10264554 ↗
• InjuryJan 10, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 9 YEARS AFTER PRIMARY DUE TO STEM POTTING, HYPER FIXATION ON THE DISTAL STEM PART.

  Patient problems: Joint Disorder

  MAUDE report 9574059 ↗
• InjuryDec 2, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY CAUSED FROM A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND LINER 1 YEAR AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9393436 ↗
• InjuryApr 3, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY, 1 YEAR AND 4 MONTHS AFTER PRIMARY, DUE TO STEM SUBSIDENCE. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER WITH A MEDACTA LINER.

  Patient problems: Joint Disorder

  MAUDE report 8478392 ↗
• InjuryNov 16, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED AFTER 2 YEARS AND 9 MONTHS FROM PRIMARY DUE TO ACUTE HIP PAIN CAUSED BY LOOSENING OF THE DISTAL PART OF THE STEM. THE AMISTEM-H WAS REPLACED WITH QUADRA-R.

  Patient problems: Joint Disorder

  MAUDE report 8077514 ↗

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