AMIStem-H Proximal Coating Femoral Stems 01.18.175Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030804403), received between Oct 5, 2017 and Jul 6, 2020 — classified as 6 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 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.

• InjuryJul 6, 2020Failure to Osseointegrate

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS AFTER THE PRIMARY DUE TO TIGHT PAIN. THE STEM WAS FIXED, OSSEOINTEGRATION ON THE METAPHYSICAL PART AND NO OSSEOINTEGRATION ON THE DISTAL PART. NOW THE STEM WAS ALSO IMPLANTED WITH A VARUS INCLINATION AND THE DISTAL TIP WAS PUSHING AGAINST THE CORTICAL WALL OF THE FEMUR. THE STEM WAS A STD SIZE 5 AND WAS FAIRLY EASILY REMOVED WITH THE EXTRACTION SET. IT WAS INSTALLED CEMENTED QUADRA-C AND PUT SOME CERCLAGE WIRE ON THE GREAT TROCHANTER AND BELOW THE LESSER TROCHANTER.

  Patient problems: Joint Disorder

  MAUDE report 10232765 ↗
• InjuryApr 3, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS AFTER THE PRIMARY DUE TO TIGHT PAIN. THE STEM WAS FIXED, OSTEOINTEGRATION ON THE METAPHYSICAL PART AND NO OSTEOINTEGRATION ON THE DISTAL PART. NOW THE STEM WAS ALSO IMPLANTED WITH A VARUS INCLINATION AND THE DISTAL TIP WAS PUSHING AGAINST THE CORTICAL WALL OF THE FEMUR. THE STEM WAS A STD SIZE 5 AND WAS FAIRLY EASILY REMOVED WITH THE EXTRACTION SET. IT WAS INSTALLED CEMENTED QUADRA-C AND PUT SOME CERCLAGE WIRE ON THE GREAT TROCHANTER AND BELOW THE LESSER TROCHANTER.

  Patient problems: Joint Disorder

  MAUDE report 9920158 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ABOUT 1 YEAR AFTER PRIMARY (THE EXACT PRIMARY DATE IS UNKNOWN) DUE TO PAIN AND EXTRA-ARTICULAR IMPINGEMENT (GREATER TROCHANTER AND PROXIMAL RIM OF ACETABULUM). STEM AND HEAD HAVE BEEN REPLACED DUE TO PAIN. ALSO THE LINER HAVE BEEN SWAPPED. STEM WAS PROXIMALLY WELL INTEGRATED (WHERE THERE IS THE COATING) AND DISTALLY LOOSE (IN GENERAL NOT A STEM LOOSENING BECAUSE IS A PROXIMAL FIXATION STEM).

  Patient problems: Joint Disorder

  MAUDE report 9909844 ↗
• InjurySep 7, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF A LEG LENGTH DISCREPANCY 15 DAYS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE HEAD AND STEM.

  Patient problems: No Code Available

  MAUDE report 7854961 ↗
• InjuryJun 8, 2018Loose or Intermittent Connection

  REVISION DUE TO PAIN AND LOOSENING OF THE STEM 1 YEAR AFTER PRIMARY; RADIOGRAPHICALLY A RADIOLUCENT LINE WAS FOUND AT THE LEVEL OF THE GREATER TROCHANTER. NO SIGN INFECTION FOUND.

  Patient problems: Joint Disorder

  MAUDE report 7582507 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT COMPLAINED OF A FEBRILE INFECTIOUS SYNDROME. THE SURGEON REVISED THE PATIENT DUE TO INFECTION (STREPTOCOCCUS B), SWAPPING SUCCESSFULLY THE STEM, THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6917384 ↗