AMIStem H Femoral Stems 01.18.144Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07630030804205), received between Sep 15, 2017 and May 27, 2026 — classified as 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Osseointegration Problem

  AT ABOUT 13 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE STEM AND HEAD TO COMPETITOR STEM AND HEAD, AND REVISED THE LINER TO MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25297692 ↗
• InjuryMar 30, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO STEM LOOSENING 9 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Aseptic loosening

  MAUDE report 24711056 ↗
• InjuryFeb 11, 2025Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 8 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STEM LOOSENING. STEM, BALL HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21354695 ↗
• InjuryFeb 5, 2025Fracture; Fracture

  REVISION SURGERY DUE TO AMISTEM-H BREAKAGE AT ABOUT 10 YEARS AND 3 MONTHS FROM THE PRIMARY. THE PATIENT HAD UNDERGONE A PRIOR REVISION SURGERY (REASON UNKNOWN) 2 YEARS EARLIER, DURING WHICH THE HEAD AND CUP WERE REVISED. THE SURGEON REVISED THE STEM WITH A COMPETITOR DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21311199 ↗
• InjuryOct 23, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY DUE TO HA COATED STD STEM LOOSENING (OSTEOINTEGRATION DISORDER), AT ABOUT 8 YEARS 5 MONTHS AFTER PRIMARY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20512075 ↗
• InjurySep 22, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 6 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 AND HEAD WITH A NEW STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17798754 ↗
• InjuryMar 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AT 8 YEARS AND 3 MONTHS POST PRIMARY FOR STEM LOOSENING. ALL DEVICES REVISED SUCCESSFULLY.

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

  MAUDE report 16478709 ↗
• InjuryNov 30, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED ABOUT 4 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO ASEPTIC LOOSENING OF THE STEM. STEM, HEAD, AND LINER REVISED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885753 ↗
• InjuryNov 24, 2022Failure to Osseointegrate; Failure to Osseointegrate

  AMISTEM IMPLANTED APPROXIMATELY 6 YEARS AGO. REVISION SURGERY PERFORMED DUE TO ASEPTIC LOOSENING. WAITING FOR INFO REGARDING REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15860278 ↗
• InjuryMay 12, 2022Appropriate Device Problem Term/Code Not Available

  UNCHANGED PAIN. ESPECIALLY DURING EXERTION, AFTER WALKING 200 M, PAIN IN THE LEFT HIP OCCURS. THE PAIN IS ORIENTED ANTEROLATERALLY. PAIN AT NIGHT OR AT REST IS LESS PREDOMINANT. REVISION SURGERY PERFORMED 8 YEARS AND 6 MONTHS AFTER THE PRIMARY.

  Patient problems: Pain

  MAUDE report 14369186 ↗
• InjuryApr 6, 2022Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING 5 YEARS 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 14021285 ↗
• InjuryOct 25, 2021Failure to Osseointegrate

  THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE OF THE POTTED STEM IS UNKNOWN. 7 YEARS AFTER THE PRIMARY SURGERY, 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: Inadequate Osseointegration

  MAUDE report 12687958 ↗
• InjuryAug 26, 2021Loose or Intermittent Connection

  REVISION SURGERY WAS PERFORMED 4 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO ASEPTIC LOOSENING OF AN AMISTEM-H 4 LAT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12370513 ↗
• InjuryMay 19, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN. POST-OP X-RAYS INDICATED THAT ASEPTIC LOOSENING OF THE STEM HAD OCCURRED. THE SURGEON REVISED THE STEM, HEAD, AND LINER 4 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11847283 ↗
• InjuryDec 1, 2020Loose or Intermittent Connection

  THE SURGEON REVISED THE STEM DUE TO ASEPTIC LOOSENING OF THE STEM AFTER 6 YEARS AND 11 MONTHS FROM THE PRIMARY SURGERY. AS A ROUTINE, THE SURGEON ALSO CHANGED THE INLAY AND THE HEAD.

  Patient problems: Insufficient Information

  MAUDE report 10928287 ↗
• InjuryOct 9, 2020Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING AFTER 4 YEARS AND 8 MONTHS FROM THE PRIMARY. THE PATIENT IS VERY ACTIVE, WHAT COULD BE A REASON FOR THE STEM LOOSENING. THE STEM AND THE HEAD WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 10654672 ↗
• InjuryApr 1, 2020Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  STEM HEAD AND LINER REVISED, 8 YEARS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9909735 ↗
• InjuryNov 6, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED ON (B)(6) 2019, 4 YEARS AND 2 MONTHS AFTER THE PRIMARY, DUE TO SEPSIS. THE STEM AND HEAD WERE REVISED. AFTER FEW DAYS ON (B)(6) 2019 ALL PROSTHESIS HAS BEEN REMOVED DUE TO CONTINOUS SEPSIS.

  Patient problems: Unspecified Infection

  MAUDE report 9284071 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem

  ON THE (B)(6) 2019 WE WERE INFORMED OF A REVISION SURGERY PLANNED AND PERFORMED ON THE (B)(6) 2019, ABOUT 2 YEARS AND 9 MONTHS AFTER PRIMARY FOR INFECTION AND STEM SUBSIDENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS MULTI-RESISTENT SKIN GERM.

  Patient problems: Unspecified Infection

  MAUDE report 9096668 ↗
• InjuryFeb 15, 2019Difficult to Remove

  ON (B)(6) 2019 WE WERE INFORMED THAT A PATIENT CAME IN DUE TO PAIN, 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY. AFTER XRAY EVALUATION, LUCENT LINES AND ECTOPIC BONE GROWTH WERE PRESENT. DURING REVISION PROCEDURE, PERFORMED ON (B)(6) 2019, THE STEM WAS REMOVED WITH LITTLE DIFFICULTY AND THERE WAS NO BONY IN-GROWTH PRESENT.

  Patient problems: Pain

  MAUDE report 8343141 ↗
• InjuryNov 23, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO AMISTEM H LOOSENING 3 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 8099786 ↗
• MalfunctionOct 16, 2018Packaging Problem; Packaging Problem

  INTERNAL BLISTER DAMAGED (BROKEN). THE OUTER BLISTER WAS NOT DAMAGED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER STEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7968807 ↗
• InjurySep 20, 2018Appropriate Device Problem Term/Code Not Available

  WE WERE INFORMED ON (B)(6) 2018 THAT A REVISION SURGERY WILL BE NECESSARY DUE TO NO OSTEO-INTEGRATION FOUND MORE THAN ONE YEAR LATER FROM THE PRIMARY. UPDATE: 07 SEPTEMBER 2018: SURGEON REMOVED ALL THE DEVICE. REVISION SURGERY DONE ON (B)(6) 2018.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7893360 ↗
• InjuryMar 9, 2018Appropriate Device Problem Term/Code Not Available

  MEDACTA INTERNATIONAL WAS INFORMED ON (B)(6) 2018 BY THE SALES AGENT THAT THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNAVAILABLE. THE SURGEON REMOVED ON (B)(6) 2018 IMPLANTS AND IMPLANT A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7326621 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem

  FIVE YEARS AFTER PRIMARY A FEMORAL BONE REABSORPTION DUE TO STRESS SHIELDING WAS DETECTED IN THE PATIENT. THE SURGEON REVISED SUCCESSFULLY THE HIP SWAPPING THE STEM AND THE CERAMIC HEAD.

  Patient problems: Joint Disorder

  MAUDE report 7037228 ↗

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