AMIStem C Femoral StemsRecalls & reported problems across all models
Medacta International SA · 16 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 90
- Deaths reported
- 0
- Injuries reported
- 80
- Recalls
- 0
We found 16 models of AMIStem C Femoral Stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 90 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2017 and Aug 3, 2026 — classified as 80 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AMIStem C Femoral Stems problems
Device problems
- Appropriate Device Problem Term/Code Not Available18
- Adverse Event Without Identified Device or Use Problem15
- Loosening of Implant Not Related to Bone-Ingrowth15
- Loose or Intermittent Connection14
- Fracture5
- Tear, Rip or Hole in Device Packaging5
- Device Appears to Trigger Rejection4
- Break2
Patient problems
- Bone Fracture(s)22
- Unspecified Infection11
- Pain10
- Joint Disorder8
- No Known Impact Or Consequence To Patient8
- Aseptic loosening5
- No Code Available5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
AMIStem C Femoral Stems models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMIStem C Femoral Stems 01.18.152Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented20 reports
- AMIStem C Femoral Stems 01.18.153Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented15 reports
- AMIStem C Femoral Stems 01.18.151Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented10 reports
- AMIStem C Femoral Stems 01.18.150Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented9 reports
- AMIStem C Femoral Stems 01.18.155Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented7 reports
- AMIStem C Femoral Stems 01.18.154Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5 reports
- AMIStem C Femoral Stems 01.18.102Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- AMIStem C Femoral Stems 01.18.103Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented4 reports
- AMIStem C Femoral Stems 01.18.156Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented4 reports
- AMIStem C Femoral Stems 01.18.100Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- AMIStem C Femoral Stems 01.18.101Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3 reports
- AMIStem C Femoral Stems 01.18.157Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- AMIStem C Femoral Stems 01.18.104Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- AMIStem C Femoral Stems 01.18.106Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- AMIStem C Femoral Stems 01.18.107Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- AMIStem C Femoral Stems 01.18.158Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
Recent AMIStem C Femoral Stems adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJun 9, 2026Device Appears to Trigger Rejection
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, AND REVISED ALL COMPONENT SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25442543 ↗InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
AT ABOUT 3 YEARS AND 11 MONTHS FROM THE PRIMAR, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED ALL MEDACTA IMPLANTS TO COMPETITOR IMPLANTS. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Aseptic loosening; Implant Pain
MAUDE report 25297685 ↗InjuryFeb 26, 2026Loosening of Implant Not Related to Bone-Ingrowth
AT ABOUT 6 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN AS THE RESULT OF A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM TO A COMPETITOR STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 24454895 ↗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 ↗InjuryOct 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AFTER 5 MONTHS, THE PATIENT CAME IN DUE TO AN INFECTION, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, LINER, AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 23334293 ↗MalfunctionOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A POSTOPERATIVE FOLLOW-UP EXAMINATION, X-RAY IMAGING REVEALED CORTICAL HYPERTROPHY AT THE DISTAL PORTION OF THE STEM (RIGHT SIDE). THE PATIENT REMAINS UNDER OBSERVATION. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019 (RIGHT SIDE), (B)(6) 2019 (LEFT SIDE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23289777 ↗InjurySep 9, 2025Osseointegration Problem; Osseointegration Problem
AT ABOUT 8 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 23001778 ↗InjuryAug 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION AT ABOUT 9 YEARS AND 8 MONTHS FROM THE PRIMARY SURGERY DUE TO STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 22922930 ↗InjuryAug 27, 2025Osseointegration Problem; Osseointegration Problem
ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR A TOTAL RIGHT HIP REPLACEMENT. THE OPERATION WENT WELL, AND THE AFTER-EFFECTS WERE GOOD. ON (B)(6) 2013, THE PATIENT HAD A STEM REPLACEMENT FOLLOWING A TRAUMATIC LOOSENING. IN MAY 2025, THE PATIENT CAME IN DUE TO INCREASING PAIN. X-RAY IMAGING REVEALED ACETABULAR LOOSENING, LEADING TO THE INDICATION FOR REVISION OF THE ENTIRE HIP PROSTHESIS. ACCORDING TO THE SURGEON, THE CUP HAD BEEN MALPOSITIONED DURING THE PRIMARY PROCEDURE. INTRAOPERATIVELY, STEM DAMAGE AND INITIAL MIGRATION WERE OBSERVED, CAUSED BY STEM-CUP IMPINGEMENT DUE TO THE EXCESSIVELY ANTERIOR POSITION OF THE ACETABULAR COMPONENT. ON (B)(6) 2025 BOTH CUP AND STEM WERE REVISED. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Inadequate Osseointegration
MAUDE report 22902791 ↗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 ↗InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
AT ABOUT 9 YEARS AND 6 MONTHS, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 21974795 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 1 WEEK AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PROXIMAL FEMORAL BONE FRACTURE, IN PARTICULAR THE X-RAYS SHOW A FRACTURE OF THE MEDIAL CALCAR THAT EXTENDS INFERIORLY 3 CM FROM THE LESSER TROCHANTER. IT HAS BEEN REPORTED THAT THE PATIENT WAS MOVING HER LEG IN A CHAIR AND HEARD A LOUD POP FOLLOWED BY PAIN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 21968606 ↗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 ↗InjuryDec 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
REVISION DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE PRIMARY SURGERY WAS ON (B)(6) 2023 AND THE LINER HEAD AND STEM THAT WERE SUBSTITUTED ON (B)(6) 2024 DUE TO SIGNS OF AN INFECTION. ON (B)(6) 2024, AT ABOUT 11 MONTHS FROM THE PRECEDENT REVISION SURGERY FOR INFECTION THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 20817092 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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