AMIStem-P Collared 01.18.434Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630040720236), received between May 3, 2019 and Jun 9, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE AMISTEM-P SIZE4 TO AN AMISTEM-P SIZE5, REVISED THE D 28/DMH LINER TO A D 28/DMI LINER, REVISED THE 28MM BIOLOX HEAD S TO A SAME SIZE HEAD, AND REVISED THE MPACT DM D 56 CUP TO A MPACT DM D 58 CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25442544 ↗
• InjuryMay 27, 2026Fracture

  REVISION SURGERY DUE A PERIPROSTHETIC BONE FRACTURE BELOW THE STEM AFTER 18 DAYS FROM PRIMARY. THE SURGEON REVISED ALL MEDACTA IMPLANTS (STEM, HEAD, LINER, SHELL) TO COMPETITOR IMPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 25297696 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DAY AFTER THE PRIMARY HIP SURGERY, THE PATIENT FELT A POP AFTER TURNING. THE PATIENT WAS PERPENDICULAR TO HIS CHAIR. HE WAS GOING TO SIT IN IT, AND HE PIVOTED ON THE OPERATIVE LEG AND WENT TO SIT DOWN, AND THAT IS WHEN HE FELT A POP IN HIS LEG. THE SURGEON OBSERVED THE PATIENT SUSTAINED A FEMUR FRACTURE. THE SURGEON REVISED THE HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21752455 ↗
• InjuryFeb 26, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21467670 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FEMUR FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 21179474 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERIPROSTHETIC FEMORAL FRACTURE WAS CABLED ABOUT 1 MONTH AFTER THE PRIMARY SURGERY. FRACTURE OCCURRED DURING PHYSIOTHERAPY. THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19603234 ↗
• InjuryJun 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HIP REVISION FOR INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS POST PRIMARY THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19465970 ↗
• InjuryMay 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HIP REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 21 DAYS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19266712 ↗
• InjuryApr 25, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 2 YEARS 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 19178383 ↗
• InjuryMar 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AFTER THE PRIMARY HIP SURGERY, IN POST-OP RECOVERY, THE PATIENT SUSTAINED A DISTAL BONE FRACTURE. THE SAME DAY OF THE PRIMARY, THE SURGEON CABLED THE FRACTURE, REVISED THE MEDACTA STEM WITH A COMPETITOR STEM AND THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18957391 ↗
• InjuryMar 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY ALL THE COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 18940302 ↗
• InjuryDec 7, 2023No Apparent Adverse Event; No Apparent Adverse Event

  AFTER THE PRIMARY HIP SURGERY, IT WAS OBSERVED THAT THE PATIENT HAD SUSTAINED A FEMORAL BONE INTRA-OP FRACTURE, IN PARTICULAR THE FEMUR FRACTURED DURING THE IMPACTION OF THE FINAL IMPLANT. CABLES WERE PLACED TO FIX INTRAOPERATIVELY THE FRACTURE.AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18282477 ↗
• InjurySep 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 4 DAYS FROM THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED FROM X-RAYS THAT THE CUP WAS LEFT LATERAL AND THE NECK CUT WAS LONG AS WELL AS ANTEVERTED STEM AND ANTEVERTED CUP. ALL OF THIS LED TO A POSTERIOR IMPINGEMENT THAT CAUSED LUXATION AND REQUIRED THE REVISION OF ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Impingement

  MAUDE report 17681422 ↗
• InjuryMay 3, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 25 DAYS FROM THE PRIMARY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON WASHED OUT THE HIP AND REVISED THE STEM, BIOLOX HEAD, AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8577874 ↗