AMIStem-P Collared 01.18.435Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630040720243), received between Feb 7, 2022 and Sep 18, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AND 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETE SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23081548 ↗
• InjuryJul 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22643028 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE SURGERY, WHILE VIEWING THE POST OPERATIVE X-RAYS, A FEMORAL BONE FRACTURE BELOW THE STEM WAS NOTICED. IT IS LIKELY THAT THE FRACTURE OCCURRED DURING THE SURGERY, PROBABLY DURING THE IMPACTION OF THE STEM. THE PATIENT WILL BE MONITORED AND AFTER 6 WEEKS A CT SCANS FOR A CHECK WILL BE PERFORMED. REVISION SURGERY IS NOT PLANNED AT THE MOMENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 21033589 ↗
• InjuryDec 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20862484 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE GMK PRIMARY FEMORAL COMPONENT, INSERT AND TIBIAL TRAY AND CONVERTED THE PATIENT TO A HINGE KNEE AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18281396 ↗
• InjuryMay 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ABOUT FIVE DAYS AFTER THE PRIMARY SURGERY, A FEMORAL FRACTURE OCCURRED. THE SURGEON CONFIRMED THAT A MICROFRACTURE LINE NEAR THE DISTAL STEM WAS PRESENT ON THE X-RAY IMMEDIATELY AFTER SURGERY. ABOUT 7 DAYS AFTER THE SURGERY, OSTEOSYNTHESIS WAS PERFORMED WITH A LOCKING PLATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16885986 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

  AT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS, PERFORMED A WASHOUT AND THEN RE-IMPLANTED THE PATIENT WITH PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13469421 ↗