AMIStem H Femoral Stems 01.18.134Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 07630030804106), received between Jul 19, 2017 and Dec 20, 2025 — classified as 72 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (14 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME HAD PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 11 YEARS AND 7 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM AND REVISED THE MEDACTA LINER TO A MEDACTA LINER. NO SIGNS OF TRAUMA AND STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23858470 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Implant Pain

  MAUDE report 23858469 ↗
• InjuryNov 26, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 8 YEARS 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23655150 ↗
• InjuryMay 15, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 12 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22026166 ↗
• InjuryJan 22, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 8 YEARS FROM 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 WITH COMPETITOR COMPONENTS AND THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21206283 ↗
• InjuryDec 11, 2024Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 9 YEARS FROM THE PRIMARY THE PATIENT CAME IN REPORTING PAIN, DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20900785 ↗
• InjuryNov 13, 2024Loss of Osseointegration; Loss of Osseointegration

  REVISION AT ABOUT 12 YEARS AND 11 MONTHS POST-PRIMARY DUE TO ASEPTIC LOOSENING. THE SURGEON REVISED THE STEM, THE HEAD AND THE LINER SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20673931 ↗
• InjuryOct 9, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD PAIN AND THE SURGEON NOTICED RADIOLUCENCY AROUND STEM COMPONENT. AT ABOUT 8 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGEON TOKE 15 MINUTES TO REMOVE THE STEM FROM THE FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20406386 ↗
• InjurySep 2, 2024Migration; Migration

  AT 9 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20117924 ↗
• InjuryMay 13, 2024Osseointegration Problem; Osseointegration Problem

  AT 9 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19297225 ↗
• InjuryFeb 7, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 YEARS AFTER THE 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: Inadequate Osseointegration

  MAUDE report 18657174 ↗
• InjuryJan 12, 2024Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY DUE TO LOOSE STEM, AT ABOUT 7 YEARS 11 MONTHS AFTER PRIMARY. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18502389 ↗
• InjuryJan 8, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM AND HEAD WITH A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18465009 ↗
• InjuryOct 26, 2023Migration; Migration

  REVISION SURGERY AT 8 YEARS AND 11 MONTHS POST PRIMARY DUE TO STEM SUBSIDENCE. STEM AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 18009786 ↗
• InjuryAug 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  REVISION SURGERY FOR PERI PROSTHETIC FRACTURE AT ABOUT 11 YEAR AND 6 MONTHS POST PRIMARY. THE REASON OF BONE FRACTURE IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 17602730 ↗
• InjuryJul 25, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT 9 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17387719 ↗
• InjuryJul 20, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY AT ABOUT 7 YEARS 1 MONTH AFTER THE PRIMARY DUE TO STRESS SHIELDING AND PROXIMAL STEM LOOSENING. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY BY USING A QUADRA H.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17361808 ↗
• InjuryJul 14, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17325446 ↗
• InjuryJun 13, 2023Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 5 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A 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 17116001 ↗
• InjuryMay 31, 2023Migration; Migration

  POST-OP X-RAYS REVEALED RADIOLUCENT LINES AND STEM SINKING, MORE THAN 2 YEARS AFTER THE PRIMARY. THE BONE ABOVE THE LESSER TROCHANTER IS MISSING. THE SURGEON IS EVALUATING A POSSIBLE REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17029861 ↗
• InjurySep 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 9 YEARS AND 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE STEM NEVER OSSEOINTEGRATED AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15461311 ↗
• InjuryAug 19, 2022Osseointegration Problem; Positioning Problem; Osseointegration Problem; Positioning Problem

  AT ABOUT 4 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED AND THE STEM WAS FOUND LOOSE WHILE CUP WAS MALSEATED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15259348 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem

  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 6 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14488553 ↗
• InjuryDec 23, 2021Appropriate Device Problem Term/Code Not Available

  AT 7 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT HAD REVISION SURGERY DUE TO STEM MOBILIZATION.

  Patient problems: Joint Laxity

  MAUDE report 13078016 ↗
• InjuryNov 24, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED 3 YEARS 4 MONTHS AFTER THE PRIMARY DUE TO STEM LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 12868989 ↗

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