AMIStem H Femoral Stems 01.18.136Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07630030804120), received between Aug 25, 2017 and Nov 5, 2025 — classified as 22 injuries.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Osseointegration Problem; Osseointegration Problem

  AFTER 9 YEARS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE 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 MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23477190 ↗
• InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 7 YEARS AND 9 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN, DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20833262 ↗
• InjuryOct 7, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 9 YEARS AFTER THE 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 20383569 ↗
• InjuryJan 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AT ABOUT 12 YEARS FROM PRIMARY DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE, 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: Bone Fracture(s)

  MAUDE report 18578108 ↗
• InjuryJul 27, 2023Osseointegration Problem; Osseointegration Problem

  AT 12 YEARS AND 2 MONTHS 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 MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17405864 ↗
• InjuryMar 31, 2022Loose 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 MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 3 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13963374 ↗
• InjurySep 2, 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 MEDACTA STEM WITH A COMPETITOR STEM AND REVISED THE MEDACTA HEAD AND LINER WITH A MEDACTA HEAD AND LINER 6 YEARS AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 12412605 ↗
• InjuryMay 21, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 4 YEARS AFTER PRIMARY FOR STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11862758 ↗
• InjuryMar 25, 2021Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING, 3 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11568359 ↗
• InjuryFeb 10, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED DUE TO LOOSENING 6 YEARS 5 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE STEM AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11307402 ↗
• InjuryNov 6, 2020Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY FOR HIP STEM LOOSENING, ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. A BACTERIOLOGICAL SAMPLING WAS MADE AT THE FEMORAL LEVEL AND IT REVEALED THE PRESENCE OF STAPHYLOCOCCUS, WHICH COULD INDICATE THAT THE HIP REVISION WAS DUE TO A SEPTIC LOOSENING. MEDACTA (B)(4) IS RECOVERING MORE INFORMATION ABOUT THIS.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 10801095 ↗
• InjuryNov 3, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN, 5 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10776748 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED 3 MONTHS AFTER THE PRIMARY DUE TO PERIPROSTHETIC FRACTURE (NOT TRAUMA-RELATED). THE SURGEON REVISED THE STEM AND THE BALL HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 9719994 ↗
• InjuryOct 28, 2019Fracture

  REVISION SURGERY PERFORMED 4 YEARS AND 10 MONTHS AFTER THE PRIMARY DUE TO PAIN DUE TO A PERIPROSTHETIC BONE FRACTURE. THE CAUSE OF THE PERIPROSTHETIC FRACTURE IS UNKNOWN. THE SURGEON REVISED THE STEM AND LINER SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9243511 ↗
• InjuryOct 2, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 2 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN, AFTER INVESTIGATION THERE WAS EVIDENCE OF INFECTION. A REVISION SURGERY WAS PERFORMED AND ALL THE IMPLANTS HAVE BEE REMOVED. AN ANTIBIOTIC CEMENT WAS USED TO LIGHTLY CEMENT SMALL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 9144401 ↗
• InjuryJul 5, 2019Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PLANNED ON (B)(6) 2019, NINE YEARS AFTER THE PRIMARY DUE TO CUP AND STEM LOOSENING (NOT CONFIRMED BY THE SURGEON). MORE INFO WOULD BE AVAILABLE AFTER REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8764336 ↗
• InjuryJul 26, 2018Fracture

  DURING A PRIMARY HIP THE FEMUR FRACTURED. IT IS UNKNOWN IF THE FRACTURE OCCURRED DURING THE TRIAL PHASE OF THE FINAL IMPLANTATION. THE SURGEON ADDED CABLES TO STABILIZE THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7722397 ↗
• InjuryApr 25, 2018Loose or Intermittent Connection

  ABOUT 3 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7458392 ↗
• InjuryMar 1, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 5 YEARS AND 5 MONTHS AFTER PRIMARY. THE CAUSE IS UNKNOWN. THE STEM CAME OUT VERY EASILY, TOOK NO TIME WITH THE MEDACTA STEM EXTRACTOR.

  Patient problems: Joint Disorder

  MAUDE report 7306125 ↗
• InjuryJan 12, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS NECESSARY DUE TO BONE FRACTURE.

  Patient problems: Hip Fracture

  MAUDE report 7185746 ↗
• InjuryNov 15, 2017Loose or Intermittent Connection

  THE PATIENT FELL AND CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE CUP WAS KNOCKED LOOSE WITH THE FALL. THE SURGEON ALSO DETERMINED THAT THE PATIENT WAS INFECTED. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 7032793 ↗
• InjuryAug 25, 2017Failure To Adhere Or Bond

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING, 1 YEAR AND 5 MONTHS AFTER PRIMARY SURGERY. THE STEM WAS EASILY REMOVED WITH THE EXTRACTOR. IT SEEMS THAT THE PROSTHESIS NEVER REALLY INTEGRATED INTO THE METAPHYSEAL PART AND THE PATIENT HAS ALWAYS BEEN PAINFUL.

  Patient problems: Joint Disorder

  MAUDE report 6819962 ↗

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