AMIStem C Femoral Stems 01.18.152Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630030804274), received between Jan 17, 2018 and Aug 3, 2026 — classified as 16 injuries, 4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Implant subsidence

  Revision surgery performed at 20 days from primary due to femoral stem subsidence. Stem, head and liner successfully revised.

  Patient problems: Implant Pain

  MAUDE report 50114126 ↗
• MalfunctionJul 17, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING FEMUR PREPARATION WITH BROACH SIZE 2, THE AMISTEM-C STD. SIZE 2 REMAINED SAT UP (8 MM) AND COULD NOT BE INSERTED. THE STEM WAS REMOVED, THE CEMENT WAS REMOVED USING A DRILL, AND A SMALLER SIZE 0 WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME 2 HOURS (TOTAL SURGERY TIME 6 HOURS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529151 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20877888 ↗
• InjurySep 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17779227 ↗
• InjuryJul 6, 2022Fracture; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  DURING THE PRIMARY HIP SURGERY, WHEN THE SURGEON WAS IMPLANTING THE STEM, LOOSENING OF THE STEM OCCURRED DUE TO A VERTICAL FRACTURE TO THE CALCAR. THE FRACTURED PART WERE FIXED BY CEMENT, AND THE DIFFERENCE IN LEG LENGTH WAS ADJUSTED BY CHANGING THE SIZE OF THE HEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 14927428 ↗
• InjuryMar 31, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 3 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. 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: Pain

  MAUDE report 13963196 ↗
• InjuryApr 27, 2021Appropriate Device Problem Term/Code Not Available

  1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11731445 ↗
• InjuryFeb 3, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2021 (4 YEARS AFTER FIRST REVISION DUE TO PAIN PERFORMED ON (B)(6) 2017; STEM AND HEAD REVISED), THE PATIENT CAME IN REPORTING PAIN 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. THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2011.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11272378 ↗
• InjuryNov 11, 2020Crack

  THE HIP SURGERY WENT WELL, BUT THE SURGEON HAD NOTED A DISCREPANCY WHEN HE TRIED TO DO AN EXTERNAL KNEE ROTATION WITH THE AMIS EXTENSION TABLE, AND WHEN CHECKED THE MOBILITY OF THE LEG THERE WAS A CRACK, WHICH LEADS TO A TIBIAL FRACTURE VISIBLE BY AN IMAGE INTENSIFIER; A PLATE AND SCREW WERE POSED. NO FURTHER OPERATION WAS NEEDED TO RECOVER THIS INCIDENT. THE PATIENT ALREADY HAD A MEDICAL HISTORY OF A KNEE PROTHESIS (DATE AND DEVICES USED UNKNOWN).

  Patient problems: Bone Fracture(s)

  MAUDE report 10822497 ↗
• InjuryOct 9, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 7 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A PERI PROSTHETIC FRACTURE. THE CAUSE OF THE PERI PROSTHETIC FRACTURE IS UNKNOWN. THE SURGEON REVISED THE LINER, HEAD, CUP, AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD BAD BONE AND WAS OVERWEIGHT. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 10654671 ↗
• InjuryMay 7, 2020Material Perforation

  AFTER THE INSERTION OF THE STEM, THE SURGEON CHECKED AND DISCOVERED THE PERFORATION AT THE DISTAL SIDE OF THE STEM AT CT IMAGE. THE SURGEON WAS ABLE TO RETRIEVE THE STEM, BUT THE SURGEON WAS NOT ABLE TO RETRIEVE THE BONE CEMENT COMPLETELY. THE SURGERY FINISHED WITHOUT IMPLANTING THE FEMORAL STEM. TOTAL SURGERY TIME WAS 4.5 HOURS. 2.5 HOURS DELAY. THE SOFT TISSUES WERE HARD. REVISION SURGERY IS PLANNED, BUT THE DETAIL IS UNKNOWN AT THE MOMENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 10031941 ↗
• InjuryDec 19, 2019Unintended Movement

  REVISION SURGERY PERFORMED 1 YEAR AND 10 MONTHS AFTER THE PRIMARY DUE TO INFECTION AND IMPLANT MOBILIZATION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED THE CUP, BALL HEAD, LINER AND STEM AND INSERT A SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 9494690 ↗
• MalfunctionJun 18, 2019Packaging Problem; Packaging Problem

  THE NURSE OPENED THE IMPLANT CARTON BOX AND THE FIRST STERILE BLISTER IN WHICH THE STEM WAS CONTAINED. SHE CHECKED IT AND THERE WERE NO HOLES. ONLY AT THE OPENING OF THE SECOND BLISTER SHE FOUND THAT IT WAS SERIOUSLY DAMAGED. IT WAS BROKEN AND PIECES OF THE BLISTER WERE ON THE SIDE OF THE IMPLANT. THE SURGEON DECIDED TO USE ANOTHER IMPLANT, THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8707237 ↗
• MalfunctionMar 13, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DURING SURGERY THE SECOND BLISTER OF THE STEM WAS FOUND BROKE, A PART OF THE STEM WAS OUT OF THE PACKAGING. A NEW STEM WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8416471 ↗
• MalfunctionFeb 8, 2019Tear, Rip or Hole in Device Packaging

  DURING THE PRIMARY HIP SURGERY, IT WAS DISCOVERED THAT THE SIZE 2 AMISTEM C STERILE PACKAGING WAS DAMAGED. THERE WAS A 5 MINUTE DELAY IN THE CASE AND THE SURGEON SWAPPED TO ANOTHER STEM TO COMPLETE THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319902 ↗
• InjuryDec 27, 2018Fracture

  THE PATIENT CAME IN (1 YEAR AND 11 MONTHS AFTER PRIMARY SURGERY) COMPLAINING OF PAIN CAUSED BY A PERIPROSTHETIC FEMUR FRACTURE, NO TRAUMA REPORTED. THE SURGEON REVISED THE HEAD, STEM AND LINER.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 8199390 ↗
• InjuryMar 26, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 MEDACTA'S SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT ABOUT 10 DAYS AFTER PRIMARY SURGERY, THE SURGEON TOOK X-RAYS AND FOUND THE FEMORAL BONE WAS CRACKED. THE SURGEON DECIDED TO FOLLOW UP.

  Patient problems: Hip Fracture

  MAUDE report 7369014 ↗
• InjuryFeb 23, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 THE SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT A REVISION SURGERY IS PLANNED. AT THIS TIME WE DO NOT KNOW IF THE REASON OF THE REVISION SURGERY IS BONE FRACTURE OR STEM LOOSENING.

  Patient problems: Bone Fracture(s)

  MAUDE report 7291624 ↗
• InjuryJan 26, 2018Sticking

  ONE YEAR AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A STEM LOOSENING.

  Patient problems: Joint Disorder

  MAUDE report 7221029 ↗
• InjuryJan 17, 2018Loose or Intermittent Connection; Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 1 YEAR AFTER PRIMARY. THE STEM WAS LOOSE. THE CAUSE IS UNKNOWN.

  Patient problems: Joint Disorder

  MAUDE report 7199367 ↗

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