AMIStem H Femoral Stems 01.18.133Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 07630030804090), received between Jun 27, 2017 and Sep 9, 2026 — classified as 116 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (30 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 116 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Osseointegration Problem

  Revision surgery due to stem loosening after about 13 years and 4 months from primary. The surgeon revised the Medacta stem and head to a competitor stem and head, and revised the Head Biolox Delta dia.28 12/14-L to a Double Mobility HC Liner D 28/DMG.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 50692312 ↗
• InjuryMay 22, 2026Osseointegration Problem

  AT ABOUT 12 YEARS POST PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA FLAT PE HC LINER D 36/F TO A MEDACTA FLAT PE HC LINER D 40/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25253486 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE PATIENT HAD PRIMARY SURGERY FOR A FEMUR FRACTURE AND THAT WAS THE SITE OF THE PAIN. ABOUT 10 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE AMISTEM SIZE 3 TO A SHORTER SMS SOLID STEM SIZE 9, AND REVISED THE 36MM BIOLOX HEAD M TO A 36MM BIOLOX HEAD L. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 24738813 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 YEARS FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERIPROSTHETIC FEMORAL FRACTURE. THE SURGEON CABLED AND PLATED THE FRACTURE. NO IMPLANTS WERE REVISED OR EXPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23886578 ↗
• InjuryAug 12, 2025Osseointegration Problem; Osseointegration Problem

  REVISION AT ABOUT 9 YEARS AND 8 MONTHS AFTER PRIMARY FOR STEM LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22781805 ↗
• InjuryJun 5, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 12 YEARS AND 1 MONTH 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: Inadequate Osseointegration

  MAUDE report 22147837 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  AT ABOUT 13 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO STEM LOOSENING AND THE CAUSE IS UNKNOWN. 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: Implant Pain

  MAUDE report 22113328 ↗
• InjuryMar 26, 2025Loss of Osseointegration; Loss of Osseointegration

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

  MAUDE report 21697653 ↗
• InjuryOct 17, 2024Migration; Migration

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. ABOUT 9 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 20469758 ↗
• InjurySep 19, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20257008 ↗
• InjurySep 11, 2024Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 20188941 ↗
• InjuryJul 11, 2024Osseointegration Problem; Osseointegration Problem

  REVISION DUE TO STEM LOOSENING AT ABOUT 13 YEARS AND 4 MONTHS POST PRIMARY. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19720351 ↗
• InjuryJun 21, 2024Migration; Migration

  REVISION SURGERY AT ABOUT 8 YEARS AND 10 MONTHS POST-PRIMARY DUE TO STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19583762 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMORAL BONE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19573049 ↗
• InjuryJun 18, 2024Migration; Migration

  AT ABOUT 9 YEARS AND 1 MONTH AFTER PRIMARY, 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: Implant Pain

  MAUDE report 19557333 ↗
• InjuryFeb 28, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 6 YEARS AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18797016 ↗
• InjuryJan 17, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18526031 ↗
• InjuryJan 11, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 11 YEARS 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: Inadequate Osseointegration

  MAUDE report 18493529 ↗
• InjuryDec 5, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 8 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD, AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18266629 ↗
• InjuryDec 1, 2023Material Integrity Problem; Material Integrity Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. ABOUT 10 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18245836 ↗
• InjuryNov 23, 2023Loss of Osseointegration; Loss of Osseointegration

  ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, A REVISION WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE STEM. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18198423 ↗
• InjuryOct 25, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 10 YEARS AND 5 MONTHS FROM 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 MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND HE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18002028 ↗
• InjuryJul 28, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT CAME IN REPORTING PAIN DUE TO EXPERIENCING MULTIPLE DISLOCATIONS. THE SURGEON REPLACED SUCCESSFULLY THE CUP, HEAD AND LINER. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Implant Pain

  MAUDE report 17412680 ↗
• InjuryJun 28, 2023Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 8 YEARS 7 MONTHS 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 MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17215114 ↗
• InjuryMay 9, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY WAS PERFORMED ABOUT 6 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. STEM WAS REVISED WITH A COMPETITOR STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16893762 ↗

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