AMIStem-P Collared 01.18.442Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630040720311), received between Nov 16, 2021 and Mar 30, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Osseointegration Problem

  AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE AMISTEM-P SIZE 2 STEM TO A SIZE 3 AND REVISED THE 40 MM BIOLOX HEAD TO A SAME SIZE BIOLOX HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED TRAUMA.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24710798 ↗
• InjuryNov 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ABOUT TWO WEEKS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20758450 ↗
• InjuryOct 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20426054 ↗
• InjuryMay 4, 2023Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 3 YEARS 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16866688 ↗
• InjuryFeb 1, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY. X-RAYS SHOWED A PEDESTAL FORMATION AT THE DISTAL TIP OF THE STEM. IN ADDITION, RADIOLUCENCY WAS NOTED AROUND THE PROXIMAL PORTION OF THE STEM. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16276131 ↗
• InjuryNov 16, 2021Loosening of Implant Not Related to Bone-Ingrowth

  AT 4 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT STEM, HEAD AND LINER FOR STEM LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 12820240 ↗