AMIStem H Femoral Stems 01.18.135Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 07630030804113), received between Sep 20, 2017 and Jul 6, 2026 — classified as 1 death, 55 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (22 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Osseointegration Problem

  AT ABOUT 11 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE 36/F MPACT FLAT LINER TO A FACE CHANGING 10° PE HC LINER D 40/F. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 25714734 ↗
• InjuryMar 31, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 12 YEARS 6 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 STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21729099 ↗
• InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 9 YEAR AND 1 MONTH FROM 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, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21313022 ↗
• InjuryJul 16, 2024Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 10 YEARS 6 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

  MAUDE report 19749116 ↗
• InjuryJan 9, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY DUE TO POTTED STEM, AT ABOUT 7 YEARS 1 MONTH AFTER PRIMARY. STEM, BALL HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18474129 ↗
• InjuryDec 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AT ABOUT 7 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A HIP REVISION 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. IT IS PROBABLY THAT THE PATIENT CAME REPORTING PAIN.

  Patient problems: Implant Pain

  MAUDE report 16061011 ↗
• InjuryOct 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Unspecified Infection

  MAUDE report 15542037 ↗
• InjuryJul 6, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 2 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 MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14929583 ↗
• InjuryDec 22, 2021Osseointegration Problem; Osseointegration Problem

  AT 7 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, 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 13058618 ↗
• InjuryNov 24, 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. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 3 YEARS AND 3 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12867307 ↗
• InjurySep 29, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO STEM MOBILIZATION 7 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12545370 ↗
• InjurySep 15, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. 6 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, 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 12473082 ↗
• InjurySep 6, 2021Osseointegration Problem; Osseointegration Problem

  4 YEARS AND 8 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, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12428026 ↗
• InjuryJul 9, 2021Failure to Osseointegrate

  4 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12143121 ↗
• InjuryJun 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 THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 4 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11946036 ↗
• InjuryMar 8, 2021Loosening of Implant Not Related to Bone-Ingrowth

  AMISTEM-H DUE TO LOOSENING AND SUSPECTED LINER WEAR. CHANGE OF STEM, HEAD AND LINER 9 YEARS AND 1 MONTH AFTER PRIMARY. SECONDARY DIAGNOSIS: LUPUS ERYTHEMATODES (ED 2008 UNDER METHOTREXAT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 11436147 ↗
• InjuryFeb 11, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 10 YEARS AFTER PRIMARY SURGERY DUE TO THE STEM LOOSENING. STEM AND CERAMIC HEAD WERE REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11313715 ↗
• InjuryJan 13, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN CAUSED BY A LOOSE STEM, 4 YEARS 4 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11162447 ↗
• InjuryDec 22, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED 5 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO AN ASEPTIC LOOSENING OF THE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11053944 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM. THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD 4 YEARS AND 7 MONTHS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10634603 ↗
• InjurySep 30, 2020Loose or Intermittent Connection

  REVISION SURGERY PERFORMED, 9 YEARS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING. STEM AND HEAD HAVE BEEN SUCCESSFULLY REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 10604873 ↗
• InjurySep 15, 2020Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO STEM SUBSIDENCE. IT HAPPENED 2 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY. REVISION SURGERY DATE UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10534440 ↗
• InjuryAug 26, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND FEMORAL HEAD 4 YEARS 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10452928 ↗
• InjuryAug 5, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM, AND LINER 4 YEARS AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10366568 ↗
• InjuryJul 13, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 7 YEARS AND 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10263651 ↗

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