AMIStem H Femoral Stems 01.18.140Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030804168), received between Apr 12, 2018 and Mar 25, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2025Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 9 YEARS AND 4 MONTHS AFTER 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 21686929 ↗
• InjuryMay 26, 2023Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  AT ABOUT 8 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, 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 COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Implant Pain

  MAUDE report 17008948 ↗
• InjuryMay 8, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING. AMISTEM H WAS REVISED TO AMISTEM-C STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16885913 ↗
• InjuryFeb 1, 2023Osseointegration Problem; Osseointegration Problem

  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 IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16276132 ↗
• InjuryOct 28, 2022Loss of Osseointegration; Loss of Osseointegration

  REVISION SURGERY PERFORMED AT ABOUT AT ABOUT 6 YEARS 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY IMPLANTING A QUADRA-P CEMENTED STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691209 ↗
• InjuryDec 23, 2021Osseointegration Problem; Osseointegration Problem

  AT 4 YEARS 10 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO BAD OSSEOINTEGRATION OF THE STEM AND PAIN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13074744 ↗
• InjuryMay 19, 2021Loose or Intermittent Connection

  REVISION SURGERY 2 YEARS AND 11 MONTHS AFTER PRIMARY FOR STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11848917 ↗
• InjuryMar 11, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT ALREADY UNDERWENT REVISION SURGERY DUE TO INFECTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11462518 ↗
• InjuryDec 11, 2020Appropriate Device Problem Term/Code Not Available

  7 DAYS AFTER SURGERY FEMUR FRACTURE WAS NOTICED. THE FRACTURE WAS NOT NOTICED DURING SURGERY AND IT IS UNKNOWN WHEN IT OCCUR. FEMUR WAS SUCCESSFULLY REVISED ONE WEEK AFTER PRIMARY SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10991774 ↗
• InjuryNov 22, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PREFORMED 1 YEAR AND 5 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY CAUSED BY A LOOSE STEM. THE PATIENT HAD POOR BONE QUALITY. THE SURGEON REVISED THE HEAD, STEM, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9361086 ↗
• InjuryOct 3, 2019Fracture

  THE PATIENT HAD A THA ON THE (B)(6) 2019. ON THE (B)(6) 2019 THE SURGEON DISCOVERED A PERI-PROSTHETIC FEMUR FRACTURE. ON THE (B)(6) 2019 THE PATIENT WAS OPERATED TO FIX THE FRACTURE WITH A PLATE AND CABLES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 9150283 ↗
• InjuryApr 12, 2018Fracture

  THE PATIENT ALLEGED PAIN 9 DAYS AFTER PRIMARY: THE FEMORAL BONE WAS FOUND FRACTURED SPIRALLY. REVISION SURGERY SCHEDULED ON (B)(6) 2018. IT WILL BE FIXED WITH A WIRE. NO FURTHER INFORMATION WILL BE OBTAINED BECAUSE MEDACTA SYSTEM WAS NOT USED FOR THE REVISION SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 7425015 ↗