AMIStem H Collared Femoral Stems 01.18.234Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030804595), received between Jul 19, 2017 and Jul 10, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Osseointegration Problem

  REVISION SURGERY DUE TO STEM LOOSENING AFTER ABOUT 7 YEARS AND 6 MONTHS FROM PRIMARY. THE SURGEON REVISED THE AMISTEM H COLLARED STANDARD SIZE 4 TO A MONOBLOCK STEM D 13MM L 190MM STD, REVISED THE 36MM BIOLOX DELTA HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE, AND REVISED THE HOODED PE HC LINER D 36/F TO A FLAT PE HC LINER D 40/F AT HIS DISCRETION. XRAYS ARE UNAVAILABLE.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25778117 ↗
• InjuryApr 28, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED 4 YEARS 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. THE SURGEON REVISED THE STEM, HEAD, AND LINER.

  Patient problems: Failure of Implant

  MAUDE report 11737285 ↗
• InjuryJul 28, 2020Fracture

  AFTER THE IMPLANTATION OF AMISTEM-H STEM, THE SURGEON DISCOVERED THE FEMORAL FRACTURE IN THE XRAY. THE SURGEON FIXED THE FRACTURE WITH 2 WIRES. TOTAL SURGERY TIME WAS ABOUT 3 HOURS AND 30 MINUTES. THE SURGEON EXPRESSED AN OPINION THAT HE FELT SUBSIDENCE FEELING AFTER THE IMPLANTATION OF THE AMISTEM-H STEM. AMIS APPROACH.

  Patient problems: Bone Fracture(s)

  MAUDE report 10331332 ↗
• InjuryJul 8, 2020Device Dislodged or Dislocated

  THE PATIENT DISLOCATED HIS RIGHT HIP TWICE FOLLOWING A POSTERIOR APPROACH TOTAL HIP REPLACEMENT WHICH WAS PERFORMED ON THE (B)(6) 2020. THE SURGERY INCLUDED A MYHIP PLAN. THE SURGEON DOES NOT FAULT THE IMPLANTS HOWEVER HAS QUESTIONED THE POSITIONING OF THE IMPLANTS ON THE MYHIP PLAN. THE PLAN WAS BOOKED INCORRECTLY AS AN ANTERIOR APPROACH. DISLOCATIONS OCCURRED THE WEEK OF (B)(6). A CLOSED REDUCTION WAS PERFORMED ON BOTH OCCASIONS. IT IS UNSURE IF THE PATIENT IS DISLOCATING ANTERIORLY OR POSTERIORLY. NO REVISION SURGERY IS PLANNED AT THIS STAGE.

  Patient problems: Joint Disorder

  MAUDE report 10243922 ↗
• InjuryJun 18, 2019Device Slipped

  REVISION SURGERY AFTER 2 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY A LOOSE STEM. THE SURGEON REVISED THE STEM, LINER AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8707238 ↗
• InjuryMay 30, 2018Loose or Intermittent Connection; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 1 YEAR AND 8 MONTHS AFTER THE PREVIOUS SURGERY. THE SURGEON DETERMINED THE STEM HAD LOOSENED PROXIMALLY. A SMALL PEDESTAL FORMED AT THE DISTAL END OF THE STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTE: SECOND REVISION SURGERY FOR THE PATIENT, THE FIRST ONE WAS DUE TO INFECTION (STEM, HEAD AND LINER REPLACED) (B)(4).

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7553221 ↗
• InjuryApr 20, 2018Device Operates Differently Than Expected

  AFTER HAVING USED THE BROACH SIZE #4, THE SURGEON TRIED TO IMPLANT THE STEM SIZE #4, BUT IT FLOATED ABOUT 7MM UP. THE SURGEON REPLACED IT WITH A STEM SIZE #3. IT TOOK ABOUT 40 MINUTES FOR RETRIEVING. THE BROACH WAS NOT DEFECTIVE.

  Patient problems: No Code Available

  MAUDE report 7446376 ↗
• InjuryFeb 20, 2018Appropriate Device Problem Term/Code Not Available

  THREE DAYS AFTER PRIMARY THE SURGEON DETECTED A FEMUR FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM AND THE HEAD WITH ANOTHER COMPANY'S PRODUCT.

  Patient problems: Hip Fracture

  MAUDE report 7281745 ↗
• InjuryDec 21, 2017Fracture

  DURING SURGERY THE PATIENT'S DISTAL FEMUR FRACTURED. THE SURGEON REMOVED THE MEDACTA STEM AND REPLACED IT WAS ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS DELAYED APPROXIMATELY 3.5 HOURS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 7137933 ↗
• InjuryJul 19, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE STEM WAS LOOSE. NO TRAUMA REPORTED. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6724695 ↗