AMIStem H Femoral Stems 01.18.145Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07630030804212), received between Aug 16, 2017 and Jun 27, 2025 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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.

• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME HAD PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. AT ABOUT 7 YEARS AND A HALF AFTER PRIMARY 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 22345221 ↗
• InjuryJul 16, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT HAD PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. AT 11 YEARS AND 9 MONTHS POST PRIMARY 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: Implant Pain

  MAUDE report 19750754 ↗
• InjuryAug 31, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 6 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A DISTALLY POTTED STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR IMPLANTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17659780 ↗
• InjuryOct 14, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 8 YEARS AND 5 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 SUCCESSFULLY THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15604268 ↗
• InjuryMay 12, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AT 6 YEARS AND 5 MONTHS POST PRIMARY FOR FEMUR OSTEOLYSIS. THE SURGEON REVISED SUCCESSFULLY THE STEM.

  Patient problems: Osteolysis

  MAUDE report 14373283 ↗
• InjuryApr 20, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY FOR AMISTEM H LOOSENING 6 YEARS AND 2 MONTHS AFTER PRIMARY. STEM AND HEAD REVISED SUCCESSFULLY.

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

  MAUDE report 11692543 ↗
• InjuryMar 17, 2021Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 6 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REMOVED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER ISSUES WERE FOUND ON OTHER ITEMS REMOVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11506673 ↗
• InjuryFeb 24, 2021Break; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AFTER ABOUT 2 YEARS AFTER THE PRIMARY SURGERY DUE TO NECK STEM BREAKAGE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: Insufficient Information

  MAUDE report 11371538 ↗
• InjuryFeb 27, 2020Loosening of Implant Not Related to Bone-Ingrowth

  ASEPTIC LOOSENING MORE THAN 9 YEARS FROM THE PRIMARY SURGERY. STEM, HEAD AND LINER SUCCESSFULLY REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9763215 ↗
• InjuryDec 17, 2019Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT REPORTED THIGH PAIN AT ROUTINE FOLLOW-UP APPOINTMENT, SO HE WAS SENT FOR X-RAY AND LOOSENING OF THE PROXIMAL STEM WAS EVIDENT. THE SURGEON REVISED THE STEM ALMOST 1 YEAR AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9479712 ↗
• InjuryDec 13, 2019Device Dislodged or Dislocated

  THE PATIENT CAME IN, 6.5 YEARS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY CAUSED BY A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9465001 ↗
• InjuryOct 29, 2019Failure to Osseointegrate

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 11 MONTHS FROM THE PRIMARY DUE TO NON OSSEOINTEGRATION OF THE STEM (STEM MOBILIZATION). THE SURGEON REMOVED THE STEM MANUALLY AND REPLACE IT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9250360 ↗
• InjurySep 26, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 27-AUGUST-2019 WE WERE INFORMED THAT A REVISION SURGERY IS PLANNED ON (B)(6) ALMOST 6 YEARS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING AND PAIN.

  Patient problems: Pain

  MAUDE report 9123271 ↗
• InjuryAug 30, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PLANNED ON (B)(6) 2019 DUE TO PAIN (10 MONTHS AFTER PRIMARY SURGERY), THE STEM IS DISTALLY FIXED AND NOT IN THE PROXIMAL PART, POTTING.

  Patient problems: Pain

  MAUDE report 8949800 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem

  THE SURGEON FOUND SIGNS OF AN INFECTION 1 YEAR AND 8 MONTHS AFTER THE PRIMARY. THE PATIENT IS UNDER PHARMACOLOGICAL TREATMENT. THE REVISION SURGERY HAS NOT BEEN PERFORMED YET.

  Patient problems: Unspecified Infection

  MAUDE report 8830119 ↗
• InjuryJun 5, 2019Loose or Intermittent Connection

  ON (B)(6) 2019 WE WERE ALERTED THAT A REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2019, 4 YEARS AFTER PRIMARY, DUE TO STEM LOOSENING. THE STEM WAS HYPERFIXED DISTALLY ON THE BONE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8670155 ↗
• InjuryApr 24, 2019Loose or Intermittent Connection

  REVISION SURGERY AFTER 2 YEARS AND 11 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE STEM. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8544430 ↗
• InjuryMar 13, 2019Positioning Problem; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN, 3 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A LOOSE STEM. THE SURGEON COMMENTED THAT THE STEM APPEARED TO HAVE BEEN PLACED AT AN EXTREME VARUS ANGLE DURING THE PRIMARY SURGERY AND HE BELIEVES THIS CAUSED THE STEM TO LOOSEN OVER TIME. THE SURGEON REVISED THE STEM AND THE LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8416468 ↗
• InjuryNov 13, 2018Appropriate Device Problem Term/Code Not Available

  ON OCT 15, 2018 WE WERE INFORMED THAT 2 YEARS AND 10 MONTHS AFTER PRIMARY THE PATIENT CAME IN COMPLAINING OF PAIN. ON (B)(6) 2108 THE SURGEON REVISED THE HIP FOR A STEM POTTING (DISTAL FIXATION + PROXIMAL RADIOLUCENCY). STEM, HEAD AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8064115 ↗
• MalfunctionMay 18, 2018Packaging Problem; Packaging Problem

  STEM WAS FOUND TO BE LOOSE INSIDE PACKAGING. THIS CAUSED COATING DETACHMENT. A STEM BACK-UP WAS USED, THE PACKAGING WAS SCRATCHED.

  Patient problems: No Information

  MAUDE report 7525807 ↗
• InjuryMar 16, 2018Device Slipped

  PATIENT COMPLAINED OF PAIN 1 YEAR AND 3 MONTHS AFTER PRIMARY. THROUGH X-RAYS THE SURGEON NOTICED THAT THE STEM WAS PROXIMALLY LOOSE. DURING SURGERY THE STEM WAS FOUND VERY WELL FIXED DISTALLY AND TOOK SOME TIME TO REMOVE.

  Patient problems: Joint Disorder

  MAUDE report 7344709 ↗
• InjuryAug 16, 2017Device Slipped; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON DETERMINED THAT THE STEM HAD LOOSENED. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Disorder

  MAUDE report 6797195 ↗

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