AMIStem H Collared Femoral Stems 01.18.230Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630030804557), received between Aug 18, 2017 and Sep 27, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 6 MONTHS, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17823419 ↗
• InjuryNov 22, 2021Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 7 MONTHS AFTER PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO STEM LOOSENING. THE SURGEON REVISED THE STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12851283 ↗
• InjuryMar 31, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO STEM SUBSIDENCE 2 YEARS AND 8 MONTHS AFTER THE PRIMARY AND THE CAUSE OF STEM SUBSIDENCE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR IMPLANTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11595392 ↗
• InjuryOct 7, 2020Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN, 5 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A POTTED STEM THAT BECOMES LOOSE. THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10641812 ↗
• InjuryMay 17, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 4 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY, DUE TO FEMORAL INFLAMMATION. THE PATIENT WAS SUFFERING OF PAIN. STEM AND HEAD WERE REVISED.

  Patient problems: Inflammation

  MAUDE report 8619671 ↗
• InjuryFeb 16, 2018Device Slipped; Unstable

  THE PATIENT HAD A PRIMARY HIP ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT CAME IN DUE TO FEELING UNSTABLE. THE PATIENT WAS DISLOCATING. THE CUP WAS ANTEVERTED. THE SURGEON REVISED THE CUP, HEAD AND LINER (B)(4). ON (B)(6) 2018 THE PATIENT WAS REVISED AGAIN. THE PATIENT CAME IN COMPLAINING OF INSTABILITY DUE TO STEM LOOSENING. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7276716 ↗
• InjuryNov 15, 2017Loose or Intermittent Connection

  ON (B)(6) 2017 THE PATIENT CAME IN FOR A REVISION OF THE STEM AS IT HAD BECOME LOOSE. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7032789 ↗
• InjuryOct 26, 2017Device Operates Differently Than Expected

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM POTTED. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6979314 ↗
• MalfunctionAug 18, 2017Device Issue; Device Issue

  THE SURGEON TRIED TO IMPLANT THE AMISTEM-H COLLARED STEM SIZE 0 AFTER RASPING, BUT THE STEM WAS NOT ABLE TO FIT IN THE CANAL PREPARED WITH BROACH SIZE 0. IT WAS FLOATED ABOUT 5MM HEIGHT. THE SURGEON SIMPLY CHANGE FOR NEW STEM SIZE 00 AND IT WAS FIT AND FIXED STRONGLY. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6803628 ↗