ACTIS 101012005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295380528), received between Sep 23, 2022 and Jul 10, 2025 — classified as 3 injuries.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22467934 ↗
• InjuryDec 4, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING. THE STEM WAS EASILY REMOVED AND THERE WAS NO INGROWTH ON STEM. A C-STEM WAS IMPLANTED. DOI: (B)(6) 2023 DOR: 20 NOV 2023 UNK. HIP. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING: YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT: (B)(6) HOSPITAL, WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: LOOSENING, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. 11/20/2023, REASON FOR REVISION SURGERY. THE STEM WAS LOOSE, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IS THE PATIENT PART OF A CLINICAL STUDY: NO, (B)(4). DEVICE PROPERTY OF: PATIENT, DEVICE IN POSSESSION OF: G MAREE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW

  Patient problems: Inadequate Osseointegration

  MAUDE report 18256886 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELT UNCOMFORTABLE WITH THE CURRENT PROSTHESES. WANTED A MATCHING PROTHESES WHICH WAS A COMPETITOR HIP. THUS, THE REASON FOR REVISION AND REMOVAL. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort

  MAUDE report 15470715 ↗