AMIStem H Femoral Stems 01.18.137Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07630030804137), received between Oct 20, 2017 and Nov 21, 2025 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 YEARS AND 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON NOTED NO BONE QUALITY ISSUES. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD. HE REVISED THE MEDACTA LINER TO A MEDACTA LINER. X-RAYS UNAVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23615339 ↗
• InjuryApr 4, 2024Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY FOR AMISTEM-H LOOSENING AT 4 YEARS AND 4 MONTHS POST-PRIMARY. THE HEAD AND THE STEM WERE REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19040545 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE REASON OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18203445 ↗
• InjuryAug 26, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN IN THE THIGH AND X-RAYS INDICATED THAT THERE WAS LUCENCY IN THE STEM. THE STEM WAS LOOSE PROXIMAL AND FIXED DISTAL. 9 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12370523 ↗
• InjuryMay 26, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED 10 YEARS 6 MONTHS AFTER THE PRIMARY DUE TO ASEPTIC STEM LOOSENING. STEM AND HEAD SUCCESSFULLY REVISED.

  Patient problems: Insufficient Information

  MAUDE report 11885811 ↗
• InjuryDec 1, 2020Loose or Intermittent Connection

  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 HEAD WITH COMPETITOR PRODUCTS AND REVISED THE VERSAFITCUP DM LINER HC 52/28 WITH A VERSAFITCUP DM LINER HC 52/28 4 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10926484 ↗
• InjuryOct 28, 2020Failure to Osseointegrate; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 1 YEAR AND 5 MONTHS AFTER PRIMARY SURGERY, DUE TO PAIN. THE STEM WAS NOT OSSEOINTEGRATED. NO INFECTION FOUND.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10746076 ↗
• InjuryApr 1, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN, MORE THAN 4 YEARS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9909440 ↗
• InjuryMar 12, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 2 YEARS AND 6 MONTHS DUE TO STEM LOOSENING. INITIALLY, THE STEM WAS PLANNED TO BE REVISED, BUT DURING THE OPENING OF THE WOUND SOME PURULENCE WAS DISCOVERED AND BECAUSE OF THAT THE SURGEON DECIDED TO REMOVE THE ENTIRE PROSTHESIS AND IMPLANT A NEW HIP. THE INFECTION IS CONFIRMED, THE PATHOGEN IS PSEUDOMONAS AERUGINOSA.

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 9826673 ↗
• InjuryJan 15, 2020Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9590199 ↗
• InjuryDec 18, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 3 YEARS AND 8 MONTHS AFTER THE PRIMARY DUE TO A POTTED STEM. THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9488566 ↗
• InjuryAug 19, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD 6 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. WE WERE INFORMED ABOUT THE EVENT ON AUGUST 20TH, THE REVISION SURGERY HAS BEEN PERFORMED ON AUGUST 26TH.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8906041 ↗
• InjuryJul 29, 2019Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 3 YEARS AND 4 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY DISTALLY POTTED STEM AND LOOSE PROXIMALLY. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8836268 ↗
• InjuryMay 29, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ABOUT 6 YEARS AFTER PRIMARY REVISION SURGERY FOR STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE STEM AND THE CERAMIC HEAD AND LINER.

  Patient problems: Joint Disorder

  MAUDE report 8649828 ↗
• InjuryMar 29, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 6 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY DUE TO PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE STEM. THE SURGEON REVISED THE STEM AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8464660 ↗
• InjuryFeb 28, 2019Loose or Intermittent Connection

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION SURGERY, PLANNED FOR (B)(6) 2019, SO 5 YEARS AND TWO MONTHS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8377331 ↗
• InjuryMar 23, 2018Fracture

  THE PATIENT CAME IN COMPLAINING OF PAIN TWO WEEKS AFTER PRIMARY. THE PATIENT HAD FRACTURED HIS FEMUR. THE SURGEON IS UNSURE IF THE PATIENT FELL DUE TO THE FRACTURE OR IF THE PATIENT FELL CAUSING THE FRACTURE. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 7365111 ↗
• MalfunctionFeb 20, 2018Packaging Problem; Packaging Problem

  WHEN THE OR TECHNICIAN OPENED THE IMPLANT NOTICED THAT THE INNER PACKAGING WAS DAMAGED. THE BOX AND WRAPPING REMAINED UNDAMAGED. THE SURGEON USED A SECONDARY IMPLANT OF THE SAME SIZE COMPLETING SUCCESSFULLY AND WITHOUT DELAY THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7281910 ↗
• InjuryFeb 16, 2018Fracture

  DURING THE STEM POSITIONING A FEMUR FRACTURE WAS GENERATED. THE SURGEON COMPLETED SUCCESSFULLY THE SURGERY PERFORMING INTRAOPERATIVELY 4 BONE CERCLAGE.

  Patient problems: Hip Fracture

  MAUDE report 7276640 ↗
• InjuryFeb 16, 2018Adverse Event Without Identified Device or Use Problem

  DURING THE STEM POSITIONING A FEMUR FRACTURE WAS GENERATED. THE SURGEON COMPLETED SUCCESSFULLY THE SURGERY PERFORMING INTRAOPERATIVELY A BONE CERCLAGE.

  Patient problems: Hip Fracture

  MAUDE report 7276203 ↗
• InjuryOct 20, 2017Loose or Intermittent Connection

  SEVEN YEARS AFTER PRIMARY THE SURGEON DETECTED STEM LOOSENING AND REVISED THE PATIENT SWAPPING SUCCESSFULLY THE STEM AND THE LINER.

  Patient problems: Joint Disorder

  MAUDE report 6964491 ↗

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