AMIStem H Femoral Stems 01.18.143Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07630030804199), received between Oct 13, 2017 and Dec 22, 2025 — classified as 42 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (12 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Osseointegration Problem; Osseointegration Problem

  AFTER 12 YEARS AND 3 MONTHS POST-PRIMARY, THE PATIENT CAME IN DUE TO A POTTED STEM.THE SURGERY REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23864347 ↗
• InjuryNov 10, 2025Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 11 YEARS AND 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23510668 ↗
• InjuryJul 11, 2025Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  AFTER 7 YEARS AND 5 MONTHS FROM THE PRIMARY X-RAYS SHOWED STEM LOOSENING. THE STEM WAS EASILY REMOVED AND THE SURGERY CONCLUDED SUCCESFULLY. HEAD AND LINER WERE ALSO REVISED PER STANDARD PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479550 ↗
• InjuryApr 4, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STEM LOOSENING. THE STEM WAS NOT OSTEOINTEGRATED AND WAS REMOVED BY HAND DURING THE REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21771466 ↗
• InjurySep 26, 2024Loss of Osseointegration; Loss of Osseointegration

  REVISION FOR STEM LOOSENING AT ABOUT 8 YEARS AND 11 MONTHS POST PRIMARY, THE REASON IS UNKNOWN. STEM AND INLAY EXCHANGE HAS BEEN PERFORMED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20310909 ↗
• InjuryAug 23, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD PAIN, DUE TO A LOOSE STEM. AT ABOUT 6 YEARS AND 9 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA STEM, HEAD AND LINER WITH COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20046116 ↗
• InjuryAug 22, 2024Fracture; Device Appears to Trigger Rejection; Fracture; Device Appears to Trigger Rejection

  PRIMARY SURGERY PERFORMED ON (B)(6) 2015. FIRST REVISION SURGERY ON (B)(6) 2015 DUE TO INFECTION; DEBRIDEMENT AND JET LAVAGE PERFORMED. NO COMPONENTS REVISED. SECOND REVISION SURGERY PERFORMED ON (B)(6) 2015: JETLAVAGE AND IMPLANTATION OF VAC-SYSTEM. NO COMPONENTS REVISED. THIRD REVISION SURGERY PERFORMED ON (B)(6) 2016 DUE TO HEMATOMA. HEMATOMA REMOVED AND JETLAVAGE PERFORMED. NO COMPONENTS REVISED. FOURTH REVISION SURGERY PERFORMED ON (B)(6) 2016 DUE TO INFECTION, REMOVAL OF ALL COMPONENTS. REIMPLANTATION OF AMISTEM-H 3 LAT, MEDACTA CERAMIC HEAD, COMPETITOR'S CUP AND INLAY (CERAMIC BUT NOT MEDACTA). FIFTH REVISION SURGERY PERFORMED ON (B)(6) 2016 DUE TO CONTINUING SEROMA FORMATION. ONLY LINER AND HEAD REVISED WITH COMPETITOR'S COMPONENTS (CERAMIC BUT NOT MEDACTA). SIXTH REVISION SURGERY PERFORMED ON (B)(6) 2024 DUE TO STEM NECK BREAKAGE, AFTER A FALL EXPERIENCED BY THE PATIENT THE DAY BEFORE. IT IS UNKNOWN IF THE STEM BROKE DUE TO THE FALL OR IF THE PATIENT FELL DUE TO THE BREAKAGE OF THE IMPLANT.

  Patient problems: Hematoma; Medical device site infection

  MAUDE report 20038105 ↗
• InjuryJan 31, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 8 YEARS AND 6 MONTHS FROM 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 MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18612967 ↗
• InjuryJun 1, 2023Migration; Migration

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. ABOUT 11 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD, STEM, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17037703 ↗
• InjuryMar 17, 2023Migration; Migration

  THE PATIENT CAME IN REPORTING PAIN DUE TO STEM SUBSIDENCE (IT WAS PROBABLY UNDERSIZED). ABOUT 10 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16564942 ↗
• InjuryJul 18, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING, 8 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15041369 ↗
• InjuryMay 24, 2022Failure to Osseointegrate

  AT 5 YEARS 1 MONTH AFTER THE PRIMARY, REVISION SURGERY FOLLOWING THE ASEPTIC LOOSENING OF THE STEM DUE TO INSUFFICIENT OSSEOINTEGRATION. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14486028 ↗
• InjuryMar 17, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDER A LOT OF PAIN AND THERE WAS NO OSSEOINTEGRATION. STEM AND HEAD WERE REVISED SUCCESSFULLY 4 YEARS AND 3 MONTHS AFTER PRIMARY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13791072 ↗
• InjuryJan 20, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED 7 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION.

  Patient problems: Unspecified Infection

  MAUDE report 13304092 ↗
• InjuryNov 30, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING 10 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. QUADRA-H IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 12890276 ↗
• InjurySep 24, 2021Break

  REVISION SURGERY PERFORMED DUE TO STEM NECK BREAKAGE, 2 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY. THE STEM WAS REPLACED WITH A QUADRA R. NO OTHER REVISION SURGERIES HAVE BEEN PERFORMED WITH THIS PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12525919 ↗
• InjuryApr 7, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM 5 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR IMPLANTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11626052 ↗
• InjuryMar 3, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO STEM LOOSENING 5 YEARS 5 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE STEM LOOSENING IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11403386 ↗
• InjuryJan 27, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY WAS PERFORMED DUE TO POTTED STEM 5 YEAS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. STEM, HEAD AND LINER WERE REVISED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 11236074 ↗
• InjurySep 10, 2020Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 5 YEARS AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10513740 ↗
• InjurySep 9, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING DISCOMFORT 6 YEARS AND 8 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE DISCOMFORT IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 10507114 ↗
• InjuryJul 22, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 6 YEARS FROM THE PRIMARY SURGERY (EXACT PRIMARY DATE IS UNKNOWN, WE KNOW THAT IT WAS PERFORMED IN 2014) DUE TO STEM LOOSENING (PROXIMALLY) AND SUSPICION OF CUP LOOSENING. DURING THE REVISION, THE STEM AND LINER WERE REVISED AND THE CUP REMAINS IN PLACE AS IT WAS WELL FIXED. THE LINER 32MM WAS CAUSING AN IMPINGEMENT WITH THE PRIMARY STEM AND IT WAS REVISED TO 36MME.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10307108 ↗
• InjuryApr 15, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY ABOUT 9 YEARS AFTER PRIMARY SURGERY FOR STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE PATIENT STEM, CERAMIC HEAD AND SHELL LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9961872 ↗
• InjuryApr 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED DUE TO RADIOLUCENCY 5 YEARS AND 4 MONTHS AFTER THE PRIMARY. THE STEM HAS BEEN REPLACED WITH A BIGGER SIZE (AMISTEM-P), THE HEAD AS WELL. THE HEAD WAS NOT A MEDACTA PRODUCT.

  Patient problems: No Code Available

  MAUDE report 9932110 ↗
• InjuryMar 6, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN. THE SURGEON TOOK X-RAYS AND DETERMINED THE PATIENT HAD LOOSENING AND DISTAL POTTING. THE SURGEON REVISED THE LINER, HEAD, AND STEM 7 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9799442 ↗

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 · 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