AMIStem-P Collared 01.18.444Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040720335), received between Feb 7, 2023 and Aug 14, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2024Migration; Migration

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF PERIPROSTHETIC FEMORAL BONE FRACTURE. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD AND IMPLANTED A PLATE. IT HAS BEEN REPORTED THAT, AFTER THE PRIMARY, THE PATIENT REPORTED PAIN. DURING A CHECKUP THE STEM WAS FOUND TO BE SUBSIDED AND THE PATIENT WAS MAINTAINED UNDER OBSERVATION. DURING THE MONITORING, A BONE FRACTURE WAS CONFIRMED AFTER TRAUMATIC EVENT OF THE PATIENT. GIVEN THE SUBSIDENCE AND PAIN AFTER PRIMARY, IT HAS HYPOTHESIZED THAT AN INTRA-OP RIB OR MINOR FRACTURE OCCURRED.

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 19981688 ↗
• InjuryNov 7, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 3 YEARS AND 5 MONTHS FROM 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 COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18084407 ↗
• InjuryFeb 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  RIGHT AFTER THE PRIMARY HIP SURGERY, WHEN THE PATIENT WAS IN POST-OP RECOVERY, THE PATIENT SUSTAINED A FEMORAL FRACTURE. IT IS UNKNOWN HOW THIS FRACTURE OCCURED. THE PATIENT WAS REVISED 1 DAY AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. BONE QUALITY NORMAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 16311508 ↗