ACTIS 101012090Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295380610), received between Jun 12, 2018 and Apr 9, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE- FEMORAL-CALCAR DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: CAUSAL RELATIONSHIP. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2026. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: OBSERVATION. DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 471056000. LOT NUMBER: 5021178. COMPONENT TYPE: SHELL. DESCRIPTION: EMPHASYS ACETABULAR SHELL NO-HOLE 56MM. CATALOG NUMBER: 472256036. LOT NUMBER: 5020334. COMPONENT TYPE: LINER. DESCRIPTION: EMPHASYS POLYETHYLENE LINER AOX NEUTRAL 56-58MM 36MM. CATALOG NUMBER: 101012090. LOT NUMBER: MA1444. COMPONENT TYPE: STEM. DESCRIPTION: ACTIS DUOFIX HIP PROSTHESIS (FEMORAL STEM 12/14 TAPER CEMENTLESS SIZE 9 HIGH COLLAR) CE. CATALOG NUMBER: 136536310. LOT NUMBER: 5030261. COMPONENT TYPE: HEAD. DESCRIPTION: BIOLOX DELTA CERAMIC FEMORAL HEAD +1.5 36MM DIA 12/14 TAPER.

  Patient problems: Limb Fracture

  MAUDE report 24828809 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION DUE TO IMPLANT. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24269562 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION DUE TO INFECTION. ALONG WITH THAT TWO INSTRUMENTS WERE REPORTED FOR UNKNOWN ALLEGATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22848485 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, PATIENT WAS ADMITTED FOR TREATMENT OF A PULMONARY EMBOLISM 17 DAYS AFTER A REVISION HIP SURGERY (TO TREAT IMPLANT LINER-CUP DISASSOCIATION). DOE: (B)(6) 2023 AFFECTED SIDE: LEFT HIP. THIS IS A LINK PC OF (B)(4).

  Patient problems: Pulmonary Embolism

  MAUDE report 21996292 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT PATIENT WAS STILL SHOWING SIGNS OF INFECTION. SO, THE DOCTOR PERFORMED A FIRST STAGE REVISION BY REMOVING EVERYTHING, WASHING IT OUT EXTENSIVELY AND PUTTING NEW IMPLANTS IN. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20602535 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT INDEX THA ON (B)(6) 2024. THE PATIENT BECAME INFECTED. AND REQUIRED AN EXPLANT OF COMPONENTS AND RE-IMPLANT OF TEMPORARY SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024; DOR: (B)(6)2024; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19689507 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT SHOULD READ: PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18011072 ↗
• InjuryOct 18, 2023Migration; Migration

  ACCORDING TO THE SURGEON THE STEM WAS IMPLANTED IN (B)(6) 2022 IN BRIG BY SURGEON, HE HAD TO CHANGE IT DUE TO A MALROTATION, NOT AN IMPLANT FAILURE. DOI: (B)(6 2022, DOE: (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17959566 ↗
• InjuryJul 26, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17397647 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT HIP. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16537141 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SPIRAL FRACTURE DISTAL TO STEM IMPLANT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 16246069 ↗
• MalfunctionJan 18, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT HAIR WAS FOUND STUCK IN THE ADHESIVE IN THE STEMS PACKAGING. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194576 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT HIP WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15954151 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AND THE RESULT WAS A PROXIMAL FEMUR FRACTURE OF THE OPERATIVE SIDE. DOI: (B)(6) 2021; (B)(6) 2022 (LEFT HIP).

  Patient problems: Fall; Limb Fracture

  MAUDE report 13366064 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. ALL IMPLANTS REMOVED AND PROSTALAC IMPLANTED. DOI: (B)(6) 2019; DOR: (B)(6) 2021: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12713149 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 12360017 ↗
• InjuryJul 28, 2021Migration; Migration

  THE PATIENT WAS REVISED DUE TO ACTIS STEM SUBSIDED. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Insufficient Information

  MAUDE report 12238279 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL CAUSING A PROXIMAL FEMUR FRACTURE. SURGEON REMOVED THE ACTIS SIZE 9 HI OFFSET STEM, 36+8.5 METAL BALL, AND 36X58 NEUTSL LINER. A RECLAIM STEM WAS PLACED WITH A 36+5 BALL AND A 36X58 LIPPED LINER. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11087047 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION, COMPONENTS LISTED BELOW WERE REMOVED BUT THE CUP AND 3 SCREWS REMAINED. DOI:(B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10923800 ↗
• InjuryNov 30, 2020Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE HIS CALCAR. THE STEM SUBSIDED. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration

  MAUDE report 10922928 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2019; DOR: (B)(6) 2019, (LEFT SIDE).

  Patient problems: No Code Available

  MAUDE report 9553541 ↗
• InjuryJun 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS HIP STEM SUBSIDENCE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7593245 ↗