AMIStem H Femoral Stems 01.18.142Recalls & reported problems
Medacta International SA · AMIStem-H Lat. # 2 · Class 2 · Implant
All models of AMIStem H Femoral Stems (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medacta AMIStem-H femoral stem is an implant used in hip replacement surgery. The 23 reports that name it mostly describe the stem coming loose or failing to bond with the bone, leading to pain and revision surgery years after the original operation. All 23 reports involved injuries and no deaths. 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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030804182), received between Nov 17, 2017 and Feb 24, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (6 reports).
1 other recall cover devices cleared under the same FDA submission (K093944, K250450); 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.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection6
- Failure to Osseointegrate4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Osseointegration Problem3
- Adverse Event Without Identified Device or Use Problem2
- Device Slipped2
- Appropriate Device Problem Term/Code Not Available1
- Failure To Adhere Or Bond1
Patient problems
- Inadequate Osseointegration8
- Joint Disorder4
- No Code Available2
- Pain2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Aseptic loosening1
- Bone Fracture(s)1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2026Osseointegration Problem
REVISION SURGERY DUE TO ASEPTIC STEM LOOSENING ABOUT 5 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. STEM, HEAD, AND LINER REVISED.
Patient problems: Aseptic loosening
MAUDE report 24429837 ↗InjuryMar 13, 2025Osseointegration Problem; Osseointegration Problem
AT ABOUT 8 YEARS AND 9 MONTHS FROM PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO A DISTALLY POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 21591414 ↗InjuryJan 10, 2025Loss of Osseointegration; Loss of Osseointegration
AT ABOUT 9 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 21122111 ↗InjuryMay 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
AT ABOUT 5 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STEM PROXIMAL LOOSENING. NO INFECTION DETECTED. THE STEM WAS REMOVED VERY EASILY AND IT LOOKED UNDERSIZED. A COMPETITOR DEVICE HAS BEEN SUCCESSFULLY IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19389770 ↗InjuryJul 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION WAS CONFIRMED AS STAPH. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, 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 A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 17257962 ↗InjurySep 10, 2021Loose or Intermittent Connection
7 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REVISED THE STEM DUE TO PERIPROSTHETIC LOOSENING OF THE STEM (ONLY STEM WAS REVISED).
Patient problems: Insufficient Information
MAUDE report 12452038 ↗InjuryApr 21, 2021Osseointegration Problem; Unintended Movement
REVISION SURGERY PERFORMED 6 YEARS 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD, AND LINER.
Patient problems: Inadequate Osseointegration
MAUDE report 11700206 ↗InjuryJul 30, 2020Loosening of Implant Not Related to Bone-Ingrowth
6 YEARS AND 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR STEM LOOSENING. STEM AND HEAD REVISED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 10343413 ↗InjuryDec 27, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY PERFORMED 2 YEARS AFTER PRIMARY DUE TO STEM LOOSENING.
Patient problems: No Code Available
MAUDE report 9525235 ↗InjuryDec 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY PERFORMED 5 YEARS AND 9 MONTHS AFTER THE PRIMARY DUE TO ASEPTIC LOOSENING OF THE STEM. THE SURGEON REVISED THE STEM AND THE HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9450057 ↗InjuryOct 4, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED 10 MONTHS AFTER THE PRIMARY DUE TO PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM, LINER AND HEAD SUCCESSFULLY. THE IMPLANTS LOOKED WELL FIXED, THE CAUSE OF THE PAIN COULDN'T BE IDENTIFIED.
Patient problems: Pain
MAUDE report 9155333 ↗InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem
THE SURGEON FOUND SIGNS OF AN INFECTION ONE MONTH AFTER PRIMARY SURGERY. THE PATIENT IS UNDER PHARMACOLOGICAL TREATMENT. THE REVISION SURGERY HAS NOT BEEN PERFORMED YET.
Patient problems: Unspecified Infection
MAUDE report 8826048 ↗InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem
ABOUT 8 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION. THE SURGEON REVISED ALL THE DEVICE SUCCESSFULLY. THE INFECTION TYPE IS A MORAWIETZ (CLASS UNKNOWN).
Patient problems: Unspecified Infection
MAUDE report 8721215 ↗InjuryMay 29, 2019Loose or Intermittent Connection
REVISION PERFORMED AFTER 8 YEARS AND 1 MONTH FORM THE PRIMARY DUE TO PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE AMISTEM LAT SIZE 2. DURING THE REVISION THE STEM, THE HEAD AND THE INLAY WERE CHANGED.
Patient problems: Inadequate Osseointegration
MAUDE report 8649827 ↗InjuryApr 17, 2019Device Slipped
ON (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION PERFORMED ON THE NEXT DAY, 6 YEARS AND 4 MONTHS AFTER PRIMARY, DUE TO STEM LOOSENING. STEM AND CERAMIC HEAD REVISED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 8522866 ↗InjuryMar 29, 2019Loose or Intermittent Connection
REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 6 YEARS AND 5 MONTHS AFTER PRIMARY. AFTER THE REVISION, SOME COATING WAS FOUND ATTACHED TO THE STEM. THE HISTOLOGICAL ANALYSIS OUTCOME WAS NEGATIVE.
Patient problems: Inadequate Osseointegration
MAUDE report 8464674 ↗InjuryOct 17, 2018Failure to Osseointegrate
ON (B)(4) 2018 WE WERE INFORMED THAT THE SURGEON WAS GOING TO PERFORM A REVISION SURGERY 7 YEARS AFTER PRIMARY DUE TO INSUFFICIENT OSSEOINTEGRATION IN THE PROXIMAL PART OF THE STEM. ON (B)(6) 2018 THE REVISION WAS PERFORMED: THE STEM, HEAD AND LINER WERE REVISED. SURGERY COMPLETED SUCCESSFULLY. THE PATIENT HAD THE SAME ISSUE ALSO ON THE OPPOSITE LEG.
Patient problems: Inadequate Osseointegration
MAUDE report 7973278 ↗InjurySep 13, 2018Loose or Intermittent Connection
REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 6 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGEON USED ANOTHER COMPANY'S STEM AND HEAD WITH A MEDACTA LINER.
Patient problems: No Code Available
MAUDE report 7872479 ↗InjuryJun 7, 2018Fracture; Device Slipped
A FEW DAYS AFTER PRIMARY SURGERY, A FRACTURE WAS NOTICED EVEN IF THERE WAS NO SIGN OF FRACTURE IMMEDIATELY POST OP AND NO TRAUMA REPORTED AS THE REASON FOR THE FRACTURE. THE FEMUR WAS CABLED, BUT THEN THE STEM LOOSENED AND SUBSIDED. THE STEM AND HEAD WERE EXPLANTED.
Patient problems: Bone Fracture(s)
MAUDE report 7578033 ↗InjuryFeb 14, 2018Loose or Intermittent Connection
4 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 7269586 ↗InjuryJan 19, 2018Loose or Intermittent Connection
REVISION SURGERY WAS NECESSARY 5 YEARS ANF 10 MONTHS AFTER PRIMARY DUE TO STEM LOOSENING.
Patient problems: Joint Disorder
MAUDE report 7206137 ↗InjuryJan 12, 2018Failure To Adhere Or Bond
THE PATIENT COMPLAINED HIP LAXITY. 1 YEAR AND 8 MONTHS AFTER PRIMARY THE SURGEON DETECTED A STEM SUBSIDENCE AND REVISED SUCCESSFULLY THE PATIENT SWAPPING THE STEM, THE HEAD AND THE LINER.
Patient problems: Joint Disorder
MAUDE report 7185279 ↗InjuryNov 17, 2017Failure to Osseointegrate
THE PATIENT HAS PAIN AND THE SURGEON SUPPOSED A STEM LOOSENING 1 YEAR AND 6 MONTHS AFTER PRIMARY. THERE WAS NO OSSEOINTEGRATION ON THE PROXIMAL PART OF THE STEM. ON (B)(6) 2017 THE STEM WAS SUCCESSFULLY REPLACED.
Patient problems: Joint Disorder
MAUDE report 7040112 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K093944, K250450. One submission often covers many models, so check the product and lot details in each record.
- Z-0791-2013 · Dec 17, 2012 · TerminatedMedacta 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
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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