AMIStem-P 01.18.405Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630040720045), received between May 9, 2019 and May 21, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY DUE TO STEM LOOSENING CAUSED BY INFECTION. THE SURGEON REVISED THE STEM AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25242298 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  REVISION SURGERY AFTER 1 YEAR AND 2 MONTHS FROM PRIMARY DUE TO PERIPROSTHETIC INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 24711035 ↗
• InjurySep 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED ABOUT 1 MONTH AFTER THE PRIMARY SURGERY DUE TO FEMORAL BONE FRACTURE (FRACTURE AT THE LEVEL OF THE TIP). STEM AND HEAD REVISED. M-VIZION STEM IMPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20301657 ↗
• InjuryAug 22, 2024Migration; Migration

  AT ABOUT 10 MONTHS AFTER PRIMARY, REVISION SURGERY PERFORMED FOLLOWING STEM SUBSIDENCE DUE TO PERIPROSTHETIC BONE FRACTURE DETECTED BY X-RAYS THAT SHOWED A VERTICAL BONE FRACTURE RYME. ALL COMPONENTS REVISED TO M-VIZION. PATIENT'S BONE QUALITY NORMAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 20035287 ↗
• InjuryAug 17, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY 6 MONTHS AFTER PRIMARY FOR STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 12331235 ↗
• InjuryApr 21, 2021Fracture; Device Dislodged or Dislocated

  WHEN THE PATIENT WAS BEING MOVED AFTER THE PRIMARY HIP SURGERY AND WAS GETTING UP FROM A SITTING POSITION, THE PATIENT SUSTAINED A FRACTURE AND SUBSIDED STEM. THE FRACTURE CAUSED THE SUBSIDED STEM. THE SURGEON DECIDED TO REVISE THE STEM, HEAD, AND LINER 4 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11700207 ↗
• InjuryAug 5, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY REPORTING THIGH PAIN WHICH WAS CAUSED BY A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10366565 ↗
• InjuryApr 15, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  FEMUR BONE FRACTURE 1 MONTH AFTER PRIMARY SURGERY. THE STEM HAS BEEN REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9961386 ↗
• InjuryMay 9, 2019Fracture; Loose or Intermittent Connection

  ON THE (B)(6) 2019 WE WERE INFORMED OF A REVISION SURGERY PLANNED FOR AND PERFORMED ON THE (B)(6) 2019, 5 MONTHS FORM THE PRIMARY, DUE TO PAIN CAUSED BY A FRACTURED FEMUR AND SUBSIDED STEM. THE PATIENT GETTING OUT OF BED HEARD A POPPING SOUND, SHE ASSUMED IT WAS HER KNEE POPPING BUT IT WAS HER HIP FRACTURING AND THE STEM SUBSIDING (THE PATIENT IS OVERWEIGHT). THE SURGEON REVISED THE CERAMIC HEAD TO EXTEND THE PATIENT'S LEG LENGTH AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FRACTURE WAS ALREADY HEALED SO THE SURGEON CHOSE TO LEAVE THE STEM IN PLACE.

  Patient problems: Joint Disorder

  MAUDE report 8595282 ↗