AMIStem C Femoral Stems 01.18.153Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030804281), received between Jul 17, 2017 and Dec 23, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K103189); they may or may not involve this specific model.

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.

• InjuryDec 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT2 YEARS 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 23876929 ↗
• InjuryNov 8, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 15751892 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT WAS OPERATED DUE TO A PERIPROSTHETIC BONE FRACTURE, WHICH WAS PROBABLY GENERATED BY THE FIRST SURGERY. THE SURGEON REMOVED THE PROSTHESIS AND SUCCESSFULLY IMPLANTED AN AMIS-K LONG STEM AND ANOTHER 46L ENDOHEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 15247650 ↗
• InjuryJun 30, 2022Loose or Intermittent Connection; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, AND REVISED THE HEAD AND LINER TO DM. UPON DISTRACTION OF HEAD FROM LINER, THE STEM APPEARED LOOSE AND WAS EXTRACTED - THE CEMENT WAS NOT ADHERED TO THE STEM, THUS, THE STEM PULLED OUT EASILY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14873747 ↗
• InjuryMar 31, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED ABOUT 1 YEAR AFTER PRIMARY DUE TO STEM LOOSENING. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR IMPLANTS AND REVISED THE DM MEDACTA LINER WITH A DM MEDACTA LINER.

  Patient problems: Insufficient Information

  MAUDE report 13963367 ↗
• InjuryMar 5, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO STEM LOOSENING 1 YEAR 6 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE STEM LOOSENING 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 11422145 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11337496 ↗
• InjuryFeb 10, 2021Unintended Movement

  REVISION SURGERY PERFORMED DUE TO STEM MOBILIZATION 2 YEARS AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11307454 ↗
• InjuryOct 6, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY FOR STEM LOOSENING. CERAMIC HEAD, STEM AND LINER REVISED SUCCESSFULLY. THE PRIMARY SURGERY WAS IN 2016.

  Patient problems: No Code Available

  MAUDE report 10634602 ↗
• InjuryJul 10, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 1 YEAR AND 5 MONTHS AFTER THE PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 10257288 ↗
• InjuryFeb 19, 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 HEAD, STEM, AND LINER ALMOST 1 YEAR AND 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9727247 ↗
• MalfunctionJan 25, 2019Material Puncture/Hole

  DURING THE PRIMARY HIP SURGERY, IT WAS DISCOVERED THAT THERE WAS A HOLE IN THE EXTERNAL PACKAGING OF THE SIZE 3 AMISTEM C. THERE WAS A FIVE MINUTE DELAY IN THE CASE WHILE THE AGENT CHECKED HIS INVENTORY FOR ANOTHER SIZE 3 AMISTEM C. THE SURGEON HAD TO IMPLANT A SIZE 4 AMISTEM C DUE TO THE SIZE 3 NOT BEING AVAILABLE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8277557 ↗
• MalfunctionDec 19, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE PRIMARY PACKAGING WAS FOUND BROKEN DURING SURGERY, A BACK-UP IMPLANT HAS BEEN USED. WHITE FOAMS, STEM AND BLOCKER WERE IN THE CORRECT POSITION INTO THE BLISTER. THE SECONDARY PACKAGING WAS NOT DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8178704 ↗
• InjuryMay 11, 2018Loose or Intermittent Connection

  THE SURGEON NOTICED LOOSENING RADIOGRAPHICALLY 1 YEAR AND 8 MONTHS AFTER PRIMARY. THE PATIENT IS NOT IN PAIN AND WILL NOT BE REVISED.

  Patient problems: Joint Disorder

  MAUDE report 7506731 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE HIP AND REMOVED THE HEAD, LINER AND STEM. THE SURGEON CLOSED THE PATIENT UP. ON (B)(6) 2017 THE SURGEON IMPLANTED A NEW MEDACTA STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6716893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103189. One submission often covers many models, so check the product and lot details in each record.

• Z-0791-2013 · Dec 17, 2012 · Terminated
  Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur