AMIStem H Collared Femoral Stems 01.18.235Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030804601), received between Feb 15, 2018 and Nov 18, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 18, 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.

• InjuryNov 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. IN (B)(6) 2022, THE PATIENT CAME INTO THE ER BECAUSE OF A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A COMPETITOR SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR STEM AND HEAD AND MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 15824404 ↗
• InjuryJun 24, 2022Fracture; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 7 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA STEM WITH A COMPETITOR STEM AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14797521 ↗
• InjuryJul 7, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  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 IMPLANTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 7 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12126625 ↗
• InjuryFeb 27, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 5 YEARS AND 2 MONTHS FROM THE PRIMARY DUE TO POTTED STEM. THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9762414 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER 9, 2018 WE WERE INFORMED THAT A PATIENT CAME IN DUE TO SIGNS OF INFECTION 3 MONTHS AFTER THE PRIMARY SURGERY AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PLANNED TO REVISE THE STEM, HEAD AND LINER. THE REVISION WAS PLANNED FOR THE WEEK (B)(6) 2018, BUT NO FURTHER INFORMATION "HAVE" BEEN RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 8141709 ↗
• InjuryFeb 15, 2018Failure To Adhere Or Bond

  REVISION SURGERY PERFORMED AFTER 9 MONTHS FROM PRIMARY DUE TO STEM LOOSENING.

  Patient problems: Joint Disorder

  MAUDE report 7273175 ↗