AMIStem-P 01.18.406Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630040720052), received between Mar 21, 2019 and Nov 5, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Loss of Osseointegration; Loss of Osseointegration

  AFTER 1 YEAR AND 4 MONTHS, THE PATIENT PRESENTED WITH PAIN RELATED TO A LOOSE STEM, AND THE CAUSE IS UNKNOWN. THE SURGEON DIAGNOSED THE STEM AS BEING “ POTTED, & RDQUO; MEANING IT WAS DISTALLY FIXED BUT LOOSE PROXIMALLY, CREATING A “ WINDSHIELD WIPER” EFFECT. THE SURGEON REVISED THE STEM USING A COMPETITOR IMPLANT AND ALSO REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23477170 ↗
• InjuryApr 24, 2025Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 6 YEARS AND 4 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 COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21898243 ↗
• InjuryJul 19, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  HOLD FOR REVIEW (KP) THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM WAS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12187272 ↗
• InjuryDec 2, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A POTTED STEM. THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD ALMOST 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9394959 ↗
• InjuryNov 6, 2019Device Slipped; Unstable

  REVISION SURGERY PERFORMED 4 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY DUE TO A SLIGHTLY SUBSIDED STEM. THE SURGEON REVISED THE 28 MM COCR HEAD M WITH A 28 MM COCR HEAD XXL AND REVISED THE VERSAFITCUP DM LINER HC 58/28 WITH A VERSAFITCUP DM LINER HC 58/28. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9283658 ↗
• InjuryMar 21, 2019Fracture

  AFTER THE PRIMARY HIP SURGERY WAS COMPLETE, IT WAS DISCOVERED THAT THE FEMUR HAD SUSTAINED AN INTRA-OPERATIVE FRACTURE. THE SURGEON SUSPECTS THE FRACTURE OCCURRED WHEN THE STEM WAS IMPLANTED. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM FROM A SIZE 6 TO A SIZE 5 AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8439905 ↗