AMIStem-P 01.18.416Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040720151), received between Nov 7, 2019 and Feb 12, 2026 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Fracture

  AT6 YEARS 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN AS A RESULT OF A FALL. HE FELL ON HIS LEFT SIDEAND HEARD A POP IN THE RIGHT HIP. THE SURGEON OBSERVED THE X-RAYS, WHICH REVEALED THAT THE AMISTEM-P STEM HAD BROKEN. NO PREVIOUS REVISION SURGERY HAS BEEN PERFORMED. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND THE MEDACTA LINER TO A LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DESCRIBED AS VERY PHYSICALLY ACTIVE, WITH A ROBUST AND MUSCULAR BUILD.

  Patient problems: Implant Pain

  MAUDE report 24321109 ↗
• InjuryAug 23, 2024Migration; Migration

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO SUBSIDENCE OF THE CUP AND STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE CUP, LINER, HEAD AND STEM.

  Patient problems: Pain

  MAUDE report 20050064 ↗
• InjuryDec 19, 2023Osseointegration Problem; Osseointegration Problem

  ABOUT 1 YEAR AND 5 MONTHS, THE PATIENT WAS REPORTING PAIN AND A REVISION SURGERY WAS PERFORMED DUE TO STEM MOBILIZATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18354868 ↗
• InjuryMar 22, 2021Fracture

  3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN WITH A PERIPROSTHETIC FRACTURE. THE SURGEON REPORTED THAT IT WAS A STRESS FRACTURE WITHOUT TRAUMA. THE SURGEON FIXED THE FRACTURE SUCCESSFULLY. NO IMPLANTS WERE REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11539593 ↗
• DeathNov 7, 2019Adverse Event Without Identified Device or Use Problem

  ABOUT 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR A DISLOCATION. ACETABULAR COMPONENTS FROM A COMPETITOR. WHEN THE PATIENT WAS OPENED THE SURGEON NOTICED AN INFECTION AND DECIDED TO REMOVE ALL THE IMPLANTS. AFTER ADDING CEMENT OF COMPETITOR (NO MEDACTA CEMENT USED) THE PATIENT WENT THROUGH PULMONARY EMBOLISM AND PASSED AWAY. THE SURGEON WAS IMPLANTING ONLY COMPETITOR IMPLANTS.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 9290196 ↗