AMIStem-P 01.18.402Recalls & reported problems
Medacta International SA · AMIStem-P Std. #2 · Class 2 · Implant
All models of AMIStem-P (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medacta AMIStem-P hip implant stem used in hip replacement surgery. It has 24 adverse event reports, all describing injuries and no deaths. Reports mostly describe the stem loosening or sinking within months or years of surgery, along with bone fractures, poor bone bonding and infections, often requiring revision surgery. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07630040720014), received between Dec 19, 2018 and Nov 28, 2025 — classified as 24 injuries.
The most frequently reported specific device problem is “Fracture” (6 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available8
- Fracture6
- Loose or Intermittent Connection5
- Osseointegration Problem3
- Adverse Event Without Identified Device or Use Problem2
- Device Appears to Trigger Rejection2
- Inadequacy of Device Shape and/or Size2
- Difficult to Remove1
Patient problems
- Bone Fracture(s)8
- Inadequate Osseointegration7
- Medical device site infection2
- Pain2
- Failure of Implant1
- Hip Fracture1
- Joint Disorder1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 5 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA IMPLANTS AND PUT IN COMPETITOR SPACERS WITH ANTIBIOTIC CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 23669494 ↗InjuryJun 18, 2025Implant subsidence; Implant subsidence
THE PATIENT HAD PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. AT ABOUT 3 MONTHS FROM PRIMARY THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 22269520 ↗InjuryApr 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT 5 YEARS 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 21771298 ↗InjuryJan 10, 2025Osseointegration Problem; Osseointegration Problem
THE PATIENT HAD PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. AT ABOUT 4 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 21122214 ↗InjuryJul 25, 2024Osseointegration Problem; Osseointegration Problem
AT ABOUT 1 YEAR 3 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 THE STEM AND HEAD.. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 19827031 ↗InjuryApr 28, 2023Osseointegration Problem; Osseointegration Problem
AT ABOUT 3 YEARS 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY FOLLOWING ASEPTIC STEM LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 16831309 ↗InjuryJul 21, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED DUE TO STEM AND CUP LOOSENING 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY. NO INFECTION DETECTED.
Patient problems: Inadequate Osseointegration
MAUDE report 15074525 ↗InjuryJun 17, 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 OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD 3 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 14732902 ↗InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY PERFORMED AFTER 9 MONTHS FROM THE PRIMARY SURGERY DUE TO AN INFECTION. ALL IMPLANTS WERE REVISED.
Patient problems: Unspecified Infection
MAUDE report 12438441 ↗InjuryJul 22, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY FOR STEM LOOSENING 3 MONTHS AFTER PRIMARY THR. THE SURGERY WAS COMPLETED SUCCESSFULLY, STEM AND HEAD REVISED SUCCESSFULLY.
Patient problems: Failure of Implant
MAUDE report 12210365 ↗InjuryJun 11, 2021Appropriate Device Problem Term/Code Not Available
2 MONTHS AFTER THE PRIMARY, PERIPROSTHETIC FEMORAL FRACTURE. STEM AND HEAD SUCCESSFULLY REVISED.
Patient problems: Bone Fracture(s)
MAUDE report 11981288 ↗InjuryMay 21, 2021Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE PATIENT'S OPERATED LEG WAS LONGER THAN THEN NON-OPERATED LEG. THE PATIENT HAD PELVIC OBLIQUITY ISSUES AND ON X-RAYS THE LEGS LOOKED EQUAL, BUT CLINICALLY THE PATIENT WAS LONG ON THE OPERATED SIDE. 1 YEAR AND 8 MONTHS AFTER PRIMARY THE SURGEON REVISED SUCCESSFULLY THE PATIENT STEM, HEAD AND LINER.
Patient problems: Pain
MAUDE report 11862763 ↗InjuryApr 21, 2021Loose or Intermittent Connection; Unintended Movement
REVISION SURGERY 4 MONTHS AFTER THE PRIMARY SURGERY FOR STEM MOBILIZATION.
Patient problems: Inadequate Osseointegration
MAUDE report 11700205 ↗InjuryMar 31, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY 1 WEEK AFTER PRIMARY SURGERY. THE REASON IS ABOUT 2CM FEMUR SPIRAL FRACTURE ON THE LESSER TROCHANTER AND A SMALL FRACTURE ON THE GREAT TROCHANTER CAUSING STEM SUBSIDENCE. THE FEMUR DEVICES HAVE BEEN REPLACED AND THE FRACTURES FIXED WITH COMPETITOR DEVICES.
Patient problems: Bone Fracture(s)
MAUDE report 11595555 ↗InjuryDec 14, 2020Fracture
THE PATIENT CAME IN, 6 DAYS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE OF THE FEMUR AND THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND CABLED THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 11003731 ↗InjuryOct 13, 2020Loose or Intermittent Connection
REVISION SURGERY PERFORMED DUE TO STEM LOOSENING, PROXIMALLY, 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 10669526 ↗InjuryAug 11, 2020Fracture
THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE. THE CAUSE OF IT IS UNKNOWN. PRIMARY ON THE (B)(6) 2020. THE SURGEON PLANS TO REVISE THE STEM. NO REVISION HAS BEEN SCHEDULED AT THIS TIME.
Patient problems: Bone Fracture(s)
MAUDE report 10389666 ↗InjuryJun 25, 2020Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING A LEG LENGTH DISCREPANCY. PRIMARY CASE WAS AMIS AND THERE WERE NO TROUBLE DURING STEM IMPLANTATION. THE SURGEON CHECKED THE LEG LENGTH USING A OVERLAY ON THE C-ARM IMAGE OF A SCOUT FILM. HOWEVER, SOMETIMES HE HAD TO ADJUST THE BED HEIGHT AND THE IMAGES ARE OFF. THE STEM SET PROUD (HIGHER THAN IT SHOULD HAVE BEEN IN RELATION TO THE FEMUR) AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM AND HEAD 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 10193922 ↗InjuryMar 25, 2020Fracture; Appropriate Device Problem Term/Code Not Available
THE PATIENT HAD HIP PAIN DUE TO FEMUR CALCAR FRACTURE. THE CAUSE OF THE CALCAR FRACTURE IS UNKNOWN. 1 MONTH AFTER PRIMARY SURGERY THE SURGEON REVISED SUCCESSFULLY THE STEM AND THE CERAMIC BALL HEAD.
Patient problems: Bone Fracture(s)
MAUDE report 9880867 ↗InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY PERFORMED ONE WEEK AFTER THE PRIMARY SURGERY, DUE TO FEMORAL FRACTURE. THE SURGEON DECIDED TO USE A STAPPING TO CONTAIN THE FRACTURE, NO IMPLANT REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON FOR THE FRACTURE IS UNKNOWN.
Patient problems: Bone Fracture(s)
MAUDE report 9799437 ↗InjuryNov 14, 2019Fracture
DURING THE FINAL STEM INSERTION THE GREAT TROCHANTER FRACTURED. THE SURGEON DECIDED TO REPLACE THE STEM AND TO USE CERCLAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 9320274 ↗InjuryJun 19, 2019Fracture
THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A FRACTURED FEMUR 7 DAYS AFTER PRIMARY. THE FRACTURE OCCURRED WHILE THE PATIENT WAS STANDING ON ONE LEG AND PUTTING THEIR PANTS ON. NO IMPLANTS WERE REVISED. THE SURGEON CABLED THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Hip Fracture
MAUDE report 8711165 ↗InjuryJan 18, 2019Insufficient Device Problem Information
9 DAYS AFTER THE PRIMARY THE PATIENT PRESENTED A FRACTURE AT THE LEVEL OF THE LESSER TROCHANTER. THE SURGEON REVISED THE STEM AND THE CERAMIC HEAD SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 8260595 ↗InjuryDec 19, 2018Difficult to Remove; Positioning Problem
REVISION SURGERY 1 MONTH AND HALF AFTER THE PRIMARY SURGERY BECAUSE THE STEM WAS TOO DEEP (1 CM), SURGEON WANTED TO REMOVE THE STEM AND PUT A CEMENTED AMISTEM. THE STEM WAS IMPOSSIBLE TO BE REMOVED, SO HE DECIDED TO KEEP THE STEM AND REPLACE THE OTHERS IMPLANTS.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8178701 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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