AMIStem H Collared Femoral Stems 01.18.232Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030804571), received between Aug 25, 2017 and May 13, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Osseointegration Problem

  AT ABOUT 7 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO COMPETITOR DEVICES AND REPLACED THE MEDACTA LINER WITH A SAME-SIZE LINER.THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTS OF TRAUMA.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25160336 ↗
• InjuryMay 5, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Insufficient Information

  MAUDE report 14287036 ↗
• InjuryApr 26, 2022Osseointegration Problem; Osseointegration Problem

  AT 5 YEARS AND 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA COMPONENTS AND REVISED THEM WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14207976 ↗
• InjuryJul 26, 2021Osseointegration Problem; Osseointegration Problem

  4 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE FEMORAL STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12223902 ↗
• InjuryJun 7, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  PERIPROSTHETIC FRACTURE 2 WEEKS AFTER SURGERY. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 11946671 ↗
• InjuryFeb 19, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM 4 YEARS 2 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11347288 ↗
• InjuryFeb 8, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN AFTER 5 YEARS AND 11 MONTHS FROM THE PRIMARY SURGERY DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11292059 ↗
• InjurySep 3, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD (4 YEARS AND 5 MONTHS AFTER PRIMARY) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10487272 ↗
• InjuryOct 23, 2019Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN, ABOUT THREE YEARS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A LOOSE FEMORAL STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9222732 ↗
• InjuryJan 4, 2019Problem with Sterilization

  DURING THE PRIMARY HIP SURGERY, THE SCRUB TECH NOTICED THAT THE STEM PACKAGING WAS COMPROMISED. SECONDARY BLISTER TYVEK PEALED BACK ON THE CORNER. THE SURGEON USED ANOTHER STEM TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT DELAY. THE PACKAGING WAS DISCARDED AFTER SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8217192 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON THE SAME DAY OF THE PRIMARY DUE TO BONE FRACTURE DISCOVERED ON THE POST-OP XRAYS. NO IMPLANT WAS REMOVED, THE FRACTURE WAS CABLED.

  Patient problems: Bone Fracture(s)

  MAUDE report 8023977 ↗
• InjurySep 12, 2018Fitting Problem

  ABOUT 4 YEARS AND A HALF AFTER PRIMARY, THE SURGEON REVISED THE PATIENT FOR STEM POTTING. STEM, HEAD AND LINER SWAP PERFORMED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 7868587 ↗
• InjuryAug 30, 2018Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO STEM LOOSENING 10 DAYS AFTER PRIMARY. THE SURGEON REVISED STEM, CUP, HEAD AND LINER.

  Patient problems: Failure of Implant

  MAUDE report 7832923 ↗
• InjuryApr 19, 2018Device Operates Differently Than Expected

  THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AND 3 MONTHS AFTER THE PRIMARY. THE STEM POTTED. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT, THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7442496 ↗
• InjuryAug 25, 2017Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THERE WAS NO BONE GROWTH ON THE IMPLANT WHICH CAUSED THE INSTABILITY. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Disorder

  MAUDE report 6819951 ↗