AMIStem-P 01.18.403Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07630040720021), received between Mar 28, 2019 and May 22, 2026 — classified as 1 death, 27 injuries.

The most frequently reported specific device problem is “Fracture” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Fracture

  THE PATIENT CAME IN PRESENTING PAIN DUE TO A PERIPROSTHETIC FRACTURE RESULTING IN A SUCCESSIVE STEM SUBSIDENCE BUT THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. AT 21 DAYS POST PRIMARY THE SURGEON CABLED THE FRACTURE AND REVISED THE AMISTEM-P SIZE 3 TO A DISTAL STEM D 13MM L 140MM AND REVISED THE BIOLOX 36MM HEAD S TO A BIOLOX 36MM HEAD M. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25253490 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT TWO WEEKS FROM THE PRIMARY SURGERY, THE PATIENTCAME IN FROM PAIN DUE TO A DISTAL FRACTURE OF THE FEMUR. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 24674592 ↗
• InjuryOct 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE ENTIRE HIP SYSTEM WHILE UPSIZING THE HEAD, LINER AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23336123 ↗
• InjuryJul 2, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT UNDERWENT PRIMARY HIP SURGERY IN (B)(6) 2022. POSTOP OUTCOME NORMAL, PATIENT SATISFIED. SINCE JANUARY 2024 THE PATIENT REPORTED THIGH PAIN AND LIMPING. ASEPTIC LOOSENING DETECTED ON RADIOLOGICAL EXAMINATION. REVISION OPERATION PERFORMED ON (B)(6) 2025. STEM WAS REMOVED VIA POSTERIOR APPROACH AND AN AMISTEM-C SIZE 4 STD STEM WAS IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22381440 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FEMORAL FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR'S COMPONENTS AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20901409 ↗
• InjuryNov 26, 2024Implant subsidence; Implant subsidence

  THE PATIENT PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. AT ABOUT 2 WEEKS POST PRIMARY THE SURGEON REVISED THE MEDACTA 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 20787409 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 DAYS AFTER AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FEMORAL MICROFRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT'S BONE QUALITY MODERATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 20618384 ↗
• InjuryMay 23, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT UNDERGONE PRIMARY SURGERY ON (B)(6) 2023. A FIRST REVISION SURGERY HAS BEEN PERFORMED ON UNKNOWN DATE AND FOR UNKNOWN CAUSES. CERAMIC LINER AND BALL HEAD HAVE BEEN EXPLANTED AND REVISED. ON (B)(6) 2024, THE PATIENT HAS BEEN REVISED A SECOND TIME DUE STAPHYLOCOCCUS AUREUS INFECTION. ALL THE COMPONENTS HAVE BEEN SUCCESSFULLY REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19380011 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 6 DAYS AFTER PRIMARY, REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE. THE SURGEON REVISED ALL COMPONENTS SUCCESSFULLY. THE CUP WAS ALSO REVISED BECAUSE THE SURGEON PREFERRED TO GO FOR A SAFETIEST WAY AND CONVERTED TO DOUBLE MOBILITY RATHER THAN A CERAMIC CUP TO ENSURE STABILITY AND SAFETY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19178903 ↗
• InjuryOct 19, 2023Migration; Migration

  REVISION SURGERY FOR FEMUR BONE FRACTURE 2 WEEKS AFTER PRIMARY. THE STEM WAS 10MM SUBSIDED DUE TO THE FRACTURE. STEM AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17963944 ↗
• InjuryAug 4, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY DUE TO MOBILIZATION OF THE FEMORAL STEM, AT 1 YEAR AND 6 MONTHS FROM THE PRIMARY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17457534 ↗
• InjuryJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17105640 ↗
• InjuryMar 2, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY FOR STEM LOOSENING. STEM HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16467468 ↗
• InjuryMar 30, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 3 MONTHS FROM PRIMARY REVISION SURGERY FOR PERIPROSHTETIC FEMUR FRACTURE. STEM AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 13947492 ↗
• InjuryOct 25, 2021Loosening of Implant Not Related to Bone-Ingrowth

  AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, 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 12688361 ↗
• InjuryAug 31, 2021Migration; Migration

  10 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12390511 ↗
• InjuryMay 27, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  AFTER SURGERY IT WAS NOTICED A PERI PROSTHETIC FEMORAL FRACTURE. THE FEMUR WAS PREPARED WITH THE STD AMISTEM H BROACHES, FOLLOWING THE SURGICAL TECHNIQUE. AN M-VIZION SET WAS REQUESTED TO MEDACTA (B)(4) IMMEDIATELY AFTER THE FRACTURE DETECTION, IT ARRIVED AFTER 1,5H AT THE HOSPITAL AND THE PATIENT WAS RE-OPERATED THE SAME DAY. THE SURGEON PERFORMED FRACTURE CERCLAGE AND IMPLANTED M-VIZION SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11892317 ↗
• InjuryMay 19, 2021Unstable; Device Dislodged or Dislocated

  REVISION SURGERY 5 YEARS AND 2 MONTHS AFTER PRIMARY FOR KNEE INSTABILITY DUE TO FEMUR AND TIBIA SUBSIDENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY, GMK HINGE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 11847054 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, ABOUT 2 MONTHS AND A HALF AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED COMPETITOR IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11806093 ↗
• InjuryNov 6, 2020Migration; Migration

  REVISION SURGERY PERFORMED DUE TO STEM MIGRATION, DISTALLY, 4 MONTHS AFTER THE PRIMARY SURGERY. THE STEM WAS REVISED BUT WAS WELL OSSEOINTEGRATED. THE HEAD WAS REVISED AS WELL.

  Patient problems: Insufficient Information

  MAUDE report 10800344 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem

  AFTER THE INSERTING OF THE FEMORAL STEM INTO THE FEMORAL AND TRYING REPOSITION, THE SURGEON FELT ABNORMAL FEELING DURING MOVING TO HYPEREXTENSION. THE SURGEON CHECKED CT-IMAGE AND DISCOVERED THE FRACTURE OF THE GREATER TROCHANTER. THE SURGEON PERFORMED THE BONE FIXATION WITH THE K-WIRE. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. BONE QUALITY WAS POOR. SOME POROSIS WAS OBSERVED.

  Patient problems: Hip Fracture

  MAUDE report 10689617 ↗
• InjurySep 3, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 2 DAYS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A FRACTURED FEMUR. THE CAUSE OF THE FRACTURED FEMUR IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 10486973 ↗
• InjuryJul 21, 2020Fracture

  THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR 1 MONTH AFTER THE PRIMARY SURGERY. THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10301336 ↗
• InjuryMar 12, 2020Fracture

  ABOUT 2 WEEKS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT KNEE FOR A SUSPECTED INFECTION. THE SURGEON OBSERVED THAT THE PATIENT HAD EXCESSIVE DRAINAGE OF THE INCISION AREA. DURING THE SURGERY IT WAS OBSERVED THAT THE FEMUR WAS FRACTURED. THE SURGEON CABLED THE FRACTURE, THE INFECTION IS FINALLY NOT CONFIRMED.

  Patient problems: No Code Available

  MAUDE report 9822923 ↗
• InjuryJan 30, 2020Fracture

  THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER 1 MONTH AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FRACTURE MAY HAVE OCCURED DURING THE PRIMARY SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9646949 ↗