AMIStem H Femoral Stems 01.18.131Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 07630030804076), received between Jul 7, 2017 and Jul 6, 2026 — classified as 73 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (15 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 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Osseointegration Problem

  AT ABOUT 9 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON OBSERVED THAT THE CUP POSITION WAS NOT TO HIS PREFERENCE. THE SURGEON REVISED THE VERSAFITCUP CC 50 MM CUP TO A MPACT D 56 TWO-HOLE CUP, REVISED THE 36 MM COCR HEAD TO A 36 MM BIOLOX HEAD L, REVISED THE VERSAFITCUP CC TRIO 36/E LINER TO A D 36/F HOODED PE LINER, AND REVISED THE AMISTEM H STANDARD SIZE 1 STEM TO A M-VIZION D 16 MM L 140 MM STRAIGHT STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 25714728 ↗
• InjuryMar 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WITH REPLACEMENT OF A TOTAL HIP PROSTHESIS ABOUT 12 YEARS AFTER PRIMARY SURGERY DUE TO LOOSENING OF THE STEM.

  Patient problems: Aseptic loosening

  MAUDE report 24710922 ↗
• InjuryMar 10, 2026Osseointegration Problem

  AT ABOUT 9 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE WAS A LOOSE STEM. NO TRAUMA WAS REPORTED. THE SURGEON REVISED THE MEDACTA STEM AND MEDACTA HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE D 32 LINER TO A D 36 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24558228 ↗
• InjuryDec 22, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 10 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN RELATED TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO SIGNS OF TRAUMA. THE SURGEON SWAPPED THE MEDACTA HEAD AND STEM FOR A COMPETITOR HEAD AND STEM AND SWAPPED THE MEDACTA LINER FOR A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23864305 ↗
• InjuryNov 26, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 13 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN THAT WAS DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM. THE SURGEON ALSO SWAPPED THE MEDACTA LINER FOR A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23655151 ↗
• InjuryNov 5, 2025Osseointegration Problem; Osseointegration Problem

  AFTER10 YEARS AND 6 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A NEW MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23477197 ↗
• InjurySep 6, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 6 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20157275 ↗
• InjuryMay 2, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 11 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS WITH COMPETITOR COMPONENTS.

  Patient problems: Implant Pain

  MAUDE report 19229237 ↗
• InjuryApr 21, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16783325 ↗
• InjuryMar 23, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. 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: Inadequate Osseointegration

  MAUDE report 16596965 ↗
• InjuryMar 15, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 6 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16543841 ↗
• InjuryMar 2, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY PERFORMED AT ABOUT 8 YEARS 10 MONTHS AFTER THE PRIMARY DUE TO STEM LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16467464 ↗
• InjuryNov 10, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED ABOUT 6 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO IMPLANT ASEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15770538 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM WITH A COMPETITOR STEM AND REVISED THE HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15698285 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR HIP PAIN, AT 9 YEARS AND 1 MONTH POST PRIMARY THE STEM WAS REVISED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 15679265 ↗
• InjurySep 19, 2022Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 6 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15444791 ↗
• InjuryAug 25, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AT ABOUT 6 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA 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 15293684 ↗
• InjuryAug 3, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15154905 ↗
• InjuryJul 6, 2022Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 14927432 ↗
• InjuryMay 6, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISES THE STEM AND HEAD TO ANOTHER COMPANY'S PRODUCTS ALMOST 4 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14304057 ↗
• InjuryNov 25, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. AT 7 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12874308 ↗
• InjuryNov 23, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO STEM LOOSENING, THE STEM HAD AND LINER WERE REVISED. THE EXACT PRIMARY DATE IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12859341 ↗
• InjurySep 8, 2021Device Dislodged or Dislocated

  3 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12438431 ↗
• InjuryJul 13, 2021Failure to Osseointegrate

  HIP REVISION PERFORMED AFTER 3 YEARS AND 8 MONTHS FROM THE PRIMARY SURGERY DUE TO PAIN AND LACK OF OSSEOINTEGRATION. DURING THE REVISION SURGERY, AFTER THE FIRST ATTEMPTS TO REMOVE THE STEM BY ANTERIOR APPROACH, AFTER 2 HOURS WITHOUT SUCCESS, A POSTERIOR APPROACH WAS USED CREATING A FEMORAL FLAP AND THE STEM HAS BEEN REMOVED AND REPLACED BY A LONG CEMENTED STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12157569 ↗
• InjuryJul 7, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED MEDACTA STEM WITH A COMPETITOR STEM AND REVISED THE MEDACTA HEAD AND LINER WITH A MEDACTA HEAD AND LINER 5 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12126626 ↗

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