AMIStem H Femoral Stems 01.18.132Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 07630030804083), received between Jul 13, 2017 and Jul 8, 2026 — classified as 1 death, 114 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (24 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 115 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Osseointegration Problem

  AT ABOUT 12 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 25747720 ↗
• InjuryMay 12, 2026Osseointegration Problem

  AT ABOUT 9 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR FALL. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25148938 ↗
• InjuryMay 5, 2026Osseointegration Problem

  AT ABOUT 8 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR FALL. THE SURGEON REVISED THE MEDACTA HOODED D 32/D LINER TO A FLAT D 32/D LINER AND REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25077231 ↗
• InjuryApr 20, 2026Implant subsidence

  AT ABOUT 10 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE PATIENT REPORTED NO TRAUMA. THE SURGEON REVISED THE MEDACTA LINER TO A MEDACTA LINER AND REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 24924647 ↗
• InjuryMar 31, 2026Implant subsidence

  AT ABOUT 9 YEARS AND 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN ASSOCIATED WITH A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA INDICATED. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE D 32 LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 24738820 ↗
• InjuryMar 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO STEM LOOSENING AT ABOUT 10 YEARS AND 3 MONTHS POST PRIMARY. THE PATIENT HAD A PRIMARY SURGERY IN GERMANY ON BOTH THE HIP AND THE CONTRALATERAL HIP WAS ALREADY REVISED IN (B)(6) 2025 FOR STEM LOOSENING.

  Patient problems: Aseptic loosening

  MAUDE report 24603551 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  AT ABOUT 13 YEARS AND 9 MONTHS FROM THE PRIMARY,THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION.THE SURGEON PERFORMED A REVISION OF THE FEMORAL HEAD, STEM, ACETABULAR CUP, AND LINER.

  Patient problems: Medical device site infection

  MAUDE report 24208608 ↗
• InjuryJan 29, 2026Osseointegration Problem

  AT ABOUT13 YEARS AND 3 MONTHSFROM THE PRIMARY, THE PATIENT CAME IN PRESENTING HIP PAIN AND A LOOSE STEM WAS DIAGNOSED AFTER X-RAYS AND A CT SCAN. THE SURGEON REVISED THE MEDACTA LINER TO A MEDACTA LINER AND REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24208602 ↗
• InjuryNov 21, 2025Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY DUE TO HIP STEM LOOSENING.THE SPECIFIC DATE OF THE PRIMARY SURGERY IS UNKNOWN; IT IS PERFORMED IN 2015 OR 2018.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23615337 ↗
• InjuryNov 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY FOR STEM LOOSENING AT ABOUT 10 YEARS AND 5 MONTHS POST PRIMARY. ALL DEVICES REVISED SUCCESSFULLY. NO SIGNS OF INFECTION FOUND IN THE HIP.

  Patient problems: Aseptic loosening

  MAUDE report 23579952 ↗
• InjuryNov 10, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 10 YEARS FROM THE PRIMARY, REVISION SURGERY NEEDED DUE TO A LOOSE STEM. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM, HEAD AND CUP WITH COMPETITORS AND THE LINER WITH A NEW MEDACTA LINER (AN HOODED LINER INSTEAD OF THE FLAT LINER THAT WAS ORIGINALLY IMPLANTED).THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23510644 ↗
• InjurySep 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2021, THE PATIENT WAS ENROLLED IN THE AMIS CLINICAL TRIAL AND UNDERWENT PRIMARY SURGERY ON(B)(6) 2023, THE PATIENT REPORTED A SUDDEN CHANGE IN THE HIP, AND PROSTHETIC STEM LOOSENING WAS IDENTIFIED. ON (B)(6) 2024, THE SURGEON REVISED THE CUP AND THE STEM.

  Patient problems: Aseptic loosening

  MAUDE report 22991545 ↗
• InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration

  REVISION FOR STEM LOOSENING AT ABOUT 9 YEARS AND 5 MONTHS POST-PRIMARY. STEM AND HEAD REVISED SUCCESSFULLY. NO INFECTION. NO LOOSENING OF THE ACETABULAR SHELL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22574586 ↗
• InjuryMay 6, 2025Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Pain

  MAUDE report 21968714 ↗
• InjuryMar 6, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 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 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 21534691 ↗
• InjuryNov 14, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 10 YEARS AND 7 MONTHS AFTER 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: Implant Pain; Inadequate Osseointegration

  MAUDE report 20681552 ↗
• InjuryNov 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 7 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT COMPLAINED OF THIGH PAIN, AND UPON INSPECTION, A RADIOLUCENT LINE WAS FOUND TO HAVE DEVELOPED AND LOOSENING OCCURRED IN THE PROXIMAL PART. IT IS SUPPOSED THAT DISTAL LOCKING OF THE STEM HAD CAUSED BONE THICKENING, WHICH HAD RESULTED IN ATROPHY OF THE PROXIMAL PART. THE STEM, CANCELLOUS BONE SCREW, HEAD AND LINER WERE REVISED. BECAUSE THE CUP WAS SECURELY FIXED, THE SCREW WAS REMOVED AND NOT REPLACED. THE AMISTEM H WAS REMOVED AND AN AMIS-C WAS IMPLANTED, AND THE THICKENED BONE AREA WAS EXCAVATED WITH A FLEXIBLE REAMER.

  Patient problems: Implant Pain

  MAUDE report 20619234 ↗
• InjuryMay 24, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD PAIN DUE TO A DISTALLY POTTED STEM AND THE CAUSE IS UNKNOWN. AT 10 YEARS AND 9 MONTHS POST PRIMARY THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19392539 ↗
• InjuryMay 16, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 7 YEARS AND 8 MONTHS AFTER 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: Pain

  MAUDE report 19329133 ↗
• InjuryMay 13, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY DUE TO STEM LOOSENING, AT ABOUT 8 YEARS AFTER PRIMARY. STEM, HEAD AND INSERT SUCCESSFULLY REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19297227 ↗
• InjuryMar 23, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY WAS PERFORMED ABOUT 5 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM LOOSENING.

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

  MAUDE report 18965455 ↗
• InjuryJan 30, 2024Osseointegration Problem; Osseointegration Problem

  AT 8 YEARS AND 1 MONTH 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 STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18604830 ↗
• InjuryJan 5, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 YEARS AND 3 MONTHS AFTER 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 PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18450190 ↗
• InjuryOct 27, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 8 YEARS AND 11 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 HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18020055 ↗
• InjuryOct 10, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT 9 YEARS AND 11 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 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 17904608 ↗

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