AMIStem-P Collared 01.18.432Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630040720212), received between Apr 3, 2019 and Jan 9, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY WAS PERFORMED 1 YEAR AND 6 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION; THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24020867 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A POSTOPERATIVE FOLLOW-UP EXAMINATION 2 YEARS AFTER PRIMARY, X-RAY IMAGING REVEALED CORTICAL HYPERTROPHY AT THE DISTAL PORTION OF THE STEM. THE PATIENT REMAINS UNDER OBSERVATION. NO REVISION SURGERY IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310304 ↗
• InjuryOct 15, 2025Implant subsidence; Implant subsidence

  STEM SUBSIDENCE CAUSING FEMUR FRACTURE WAS FOUND DURING A POSTOPERATIVE FOLLOW-UP EXAMINATION AT 6 MONTHS FROM PRIMARY SURGERY; THE PATIENT REPORTED A SENSE OF DISCOMFORT. THE FRACTURE WAS MANAGED WITH CONSERVATIVE TREATMENT. THE PATIENT HAS POOR BONE QUALITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23290780 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA STEM AND HEAD TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 22369024 ↗
• InjuryApr 24, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 YEARS 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 21900713 ↗
• InjuryJan 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21207092 ↗
• InjuryDec 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 WEEKS FROM PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20819445 ↗
• InjuryOct 28, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 YEARS 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 20544241 ↗
• InjuryJun 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AND 1 WEEK AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19611958 ↗
• InjuryNov 24, 2023Migration; Migration

  THE PATIENT HAD PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. AT ABOUT 13 DAYS FROM PRIMARY THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18204617 ↗
• InjuryOct 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15536926 ↗
• InjuryNov 30, 2021Difficult to Remove

  WHEN THE AMISTEM-P WAS INSERTED, THE POSTERIOR PART OF THE FEMUR WAS PERFORATED. AFTER A REINFORCEMENT WITH NESPRON TAPE, IT WAS REPLACED WITH AN AMISTEM-C, BUT THE STEM FOLLOWED THE SAME ROUTE AND IT WAS NOT POSSIBLE TO FIX IT. THE CEMENT COULD NOT BE REMOVED SO A SECOND SURGERY HAS BEEN PERFORMED ON (B)(6) WITH AN AMIS-K.

  Patient problems: Bone Fracture(s)

  MAUDE report 12893674 ↗
• InjuryNov 26, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND DUE TO SIGNS OF AN INFECTION. THE CAUSE OF THE POTTED STEM IS INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12877898 ↗
• InjuryJun 18, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 YEAR 10 MONTHS AFTER THE PRIMARY DUE TO POTTED STEM. THE SURGEON SUCCESSFULLY REVISED STEM, HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12023024 ↗
• InjuryJan 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  TWO MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL STEM. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS, AND REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11115833 ↗
• InjurySep 29, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 1 YEAR AND 5 MONTHS AFTER PRIMARY SURGERY FOR A FEMORAL FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10599609 ↗
• InjuryJul 30, 2020Unstable; Device Dislodged or Dislocated

  THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY SURGERY REPORTING INSTABILITY DUE TO A SUBSIDED STEM. THE SURGEON REVISED THE STEM, LINEAR, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10343414 ↗
• InjuryJul 6, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 10232816 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information

  IMMEDIATELY AFTER THE PRIMARY HIP SURGERY HAD BEEN COMPLETED AND WHILE TAKING POST-OP X-RAYS, IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED A FRACTURED FEMUR DURING THE PRIMARY SURGERY. THE SURGEON SUSPECTS THE FRACTURE OCCURRED WHILE BROACHING. THE SURGEON CABLED THE FRACTURE AND NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8478382 ↗