AMIStem-P Collared 01.18.433Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630040720229), received between Dec 19, 2019 and Sep 9, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Osseointegration Problem

  Revision surgery after 1 year and 2 months due to stem loosening that caused pain and instability.The surgeon revised the Amistem-P Collared size3 to a SMS Collared Solid Stem LAT size11and revised the 36mm Biolox Head M to a 36mm BIOLOX Delta Head L. The surgery was completed successfully.

  Patient problems: Aseptic loosening

  MAUDE report 50692313 ↗
• InjuryApr 28, 2026Osseointegration Problem

  AT ABOUT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATIONS OF A FALL OR TRAUMA. THE SURGEON 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 25012251 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT1 YEAR 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM AND REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23837340 ↗
• InjuryMar 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AT ABOUT 2 YEARS AND 10 MONTHS POST PRIMARY. THE CUP AND STEM WERE LOOSE DUE TO THE INFECTION. ALL DEVICES REVISED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21685775 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FEMORAL BONE FRACTURE, NEAR THE DISTAL PART OF THE STEM. IT IS NOT POSSIBLE TO CONFIRM THE CAUSE OF THE FRACTURE, BUT IT WAS REPORTED THAT THE PATIENT STATED THAT HE HAD GONE FROM STANDING TO SITTING AND THAT WHEN HE WAS ABOUT TO SIT DOWN, THE FRACTURE OCCURRED. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Hip Fracture

  MAUDE report 20772612 ↗
• InjuryOct 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE CUP, STEM, HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20345104 ↗
• InjuryJul 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19814524 ↗
• InjuryMar 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED NEW PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18854203 ↗
• InjuryNov 9, 2023Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Implant Pain

  MAUDE report 18099057 ↗
• InjurySep 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING THE PRIMARY HIP SURGERY, IT WAS OBSERVED THAT THE PATIENT HAD SUSTAINED AN INTRA-OP FRACTURE. IT IS UNKNOWN AT WHICH POINT OF THE SURGERY THE FRACTURE OCCURRED. THE SURGEON BROACHED SEQUENTIALLY TO THE 3. A NON-COLLARED AMISTEM WAS IMPLANTED BUT IT SAT LOWER THAN EXPECTED. THEREFORE, IT WAS EXPLANTED (NO FRACTURES OCCUR) AND A COLLAR STEM WAS IMPLANTED. THE HIP REDUCED AND EASILY DISLOCATED. THE SECOND AMISTEM WAS REMOVED, AND USING A COBB, THE SURGEON LOCATED THE FRACTURE ON THE FEMUR LATERALLY. FINALLY, A COMPETITOR STEM WAS IMPLANTED. THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17698264 ↗
• InjuryMay 10, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 YEARS 11 MONTHS AFTER 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 THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16900773 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A GREATER TROCHANTER FRACTURE AND THE CAUSE IS UNKNOWN. ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REP SAID THAT THE SURGEON MENTIONED THAT IT IS A POSSIBILITY THAT THE FRACTURE COULD HAVE OCCURRED INTRA-OP DURING THE PRIMARY SURGERY BUT IT IS UNCERTAIN.

  Patient problems: Bone Fracture(s)

  MAUDE report 16322499 ↗
• InjuryDec 19, 2019Fracture

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF PAIN WHICH WAS DUE TO A FRACTURED FEMUR WHICH WAS CAUSED FROM FALLING. THE SURGEON CABLED THE FRACTURE, AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF PAIN AFTER A PHYSICAL THERAPY APPOINTMENT, IN WHICH THE THERAPIST FRACTURED THE LESSER TROCHANTER OFF WHILE STRETCHING THE LEG. THE SURGEON REPLACED THE MEDACTA STEM AND HEAD. THE MEDACTA CUP AND POLY IN THE PATIENT WERE NOT REPLACED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9494701 ↗