ACTIS 101011040Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295380443), received between Dec 7, 2017 and Sep 21, 2026 — classified as 1 death, 55 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 60 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had a Left total hip done on (b)(6) 2026. Patient fell and had peri prosthetic fracture. The surgeon went to remove the Actis stem and put in a reclaim mono block.Affected side: Left hip.

  Patient problems: Fall; Limb Fracture

  MAUDE report 50838843 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Infection.Affected Side: Left Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50816385 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain.DOI: UnknownDOR: (b)(6) 2026Affected Side: Left

  Patient problems: Pain

  MAUDE report 50717279 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50575646 ↗
• InjuryAug 26, 2026Osseointegration Problem

  It was reported that patient was revised due to femoral stem loosening. Loosening was at the bone to implant (Non-Cemented) interface.Affected Side: Right Hip.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50452216 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION DUE TO FEMORAL FRACTURE. THE IMPLANTS WERE REMOVED AND NEW ONES WERE PUT IN. THE PATIENT IS REPORTEDLY DOING WELL. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: Limb Fracture

  MAUDE report 24056326 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STEM AND HEAD WERE REMOVED DUE TO PPFX. THERE WAS REPORTEDLY NO HARM TO THE PATIENT, AND ALL PIECES WERE REMOVED FROM THE FIELD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 23681659 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23424303 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT/IMPLANT EXCHANGE FOR INFECTED TOTAL HIP. NO BROKEN INSTRUMENTS, NO DELAYS, NO ADVERSE EVENTS, NO FURTHER INFORMATION AT THIS TIME. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22848551 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ACTIS STEM, BIPOLAR HEAD AND ARTICUL/EZE HEAD WERE REMOVED BECAUSE OF INFECTION. ALL IMPLANTS WERE REMOVED WITHOUT ANY ISSUES. THERE WAS NO DELAY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22420853 ↗
• InjuryMay 23, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE ACTIS STEM NEVER GREW IN, NEED TO REVISE TO A RECLAIM MONOBLOCK. THERE WAS A STEM LOOSENING. THE LOOSENING INTERFACE WAS BETWEEN THE STEM AND THE BONE. NON-CEMENTED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22079026 ↗
• InjuryApr 29, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED AS THE PATIENT FELL AND HAD A FEMORAL FRACTURE. THE STEM WAS LOOSE AFTER THAT BECAUSE OF THE FALL. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 21927758 ↗
• InjuryMar 25, 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 INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21691859 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION OF ALL THE IMPLANTS DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21345764 ↗
• InjuryJan 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR RECURRENT DISLOCATIONS FOLLOWING INITIAL SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21210218 ↗
• InjuryJan 3, 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 INFECTION. INFECTED SINGLE STAGE REVISION OF RIGHT HIP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21074061 ↗
• MalfunctionDec 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. SURGEON WAS IMPLANTING THE ACTIS STEM IMPLANT, WHEN PUSHING THE IMPLANT INTO THE FEMORAL CANAL SURGEON STATED THAT THEY CAN SEE A SMALL PLUME OF WHAT APPEARS TO BE HA COATING DUST. SURGEON SAID THIS ISN¿T THE FIRST TIME HE HAS SEEN THIS BUT DID ASK IF THIS WAS NORMAL TO SEE. HE DID VOICE CONCERN IF THIS COULD CAUSE HO FORMATION AROUND THE JOINT. NO SURGICAL DELAY TO REPORT. NO PATIENT HARM. DOI: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036050 ↗
• InjuryNov 12, 2024Adverse 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. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 20662949 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? - NO B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - NO.

  Patient problems: Unspecified Infection

  MAUDE report 20586194 ↗
• InjurySep 25, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AT UNKNOWN INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20302448 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REP WAS INFORMED OF AN EVENT INVOLVING A POSSIBLE INFECTION WHILE DEPUY SYNTHES IMPLANTS WERE PLACED. IT IS UNKNOWN AT THIS TIME WHAT INTERVENTIONS HAVE TAKEN PLACE. THE SALES REP PROVIDED THE IMPLANTS PLACED DURING THE INITIAL PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 20278849 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT (RTH) IMPLANTED ON (B)(6) 2024. WHILE WALKING AFTER THE PROCEDURE, THE PATIENT PERFORATED THE FEMORAL CANAL. THE PATIENT WAS REVISED ON (B)(6) 2024. SURGEON REMOVED THE PERFORATING STEM AND HEAD. HE THEN USED A LONGER STEM TO BYPASS THE PERFORATION. THE ACETABULAM WAS WELL ALIGNED AND STABLE. IT WAS RETAINED.

  Patient problems: Limb Fracture

  MAUDE report 20249630 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL HIP ARTHROPLASTY AND NO REVISION WAS REPORTED ON LEFT HIP. INCREASED COBALT AND CHROMIUM WAS ALLEGED ON THE LEFT HIP AS WELL. DOI: (B)(6) 2019. DOR: UNKNOWN. LEFT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 19919346 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION AND NEW IMPLANTS WERE IMPLANTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18987374 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT GOT INFECTED. SURGEON CONDUCTED A 1 STAGE REVISION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18669299 ↗