ACTIS 101012070Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295380597), received between Aug 21, 2018 and Sep 17, 2026 — classified as 42 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (8 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 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient fell and broke her femur. We are revising to a reclaimDOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left hip.

  Patient problems: Fall; Limb Fracture

  MAUDE report 50805839 ↗
• InjurySep 10, 2026Osseointegration Problem

  It was reported that patient was revised for loosening of femoral stem due to fracture at the bone to implant interface (Non-Cemented). Unknown Cement Manufacturer. Patient admitted post fall with a peri prosthetic fracture post THA. Femoral stem was revised to a longer prosthesis to bypass the femoral fracture. Additional fixation was implanted to further address the fracture. No delay nor patient harm was noted. No allegation was made against any components as they were well functioning prior to this incident.DOI: (b)(6 )2024.DOR: (b)(6)-2026.Affected Side: Left.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 50717137 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had prostalac spacer for infection, right hip. Removal of all implants from original surgery date of (b)(6)2026. Affected side- Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50496624 ↗
• InjuryJul 30, 2026Osseointegration Problem

  It was reported that patient appeared for two week follow-up appointment, x-ray revealed asymptomatic Liner disassociated from cup, patient had no symptoms, pain, complaints or known complications. Intra-operative findings showed fracture in proximal femur, loose Actis stem and disassociated Emphasys DM liner. Liner was replaced, Actis stem was removed and revised with Reclaim Monoblock stem. Activity Level - YesDOI: (b)(6) 2026,DOR: (b)(6) 2026,Affected side: Right hip.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 50085994 ↗
• InjuryJul 15, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PERIPROSTHETIC FEMUR FRACTURE LOOSE STEM. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 25824973 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, IMPLANTS REMOVED. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24604267 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL INTO THE SIDE OF A COUCH CAUSING A FRACTURE AROUND THE FEMORAL STEM. THE STEM AND HEAD WERE REMOVED AND A LONGER REVISION STEM WITH CABLES WAS PLACED. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2025, DOR:(B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 24052740 ↗
• InjuryDec 18, 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 FALL AND FRACTURE, IMPLANTED (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23837419 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC REMOVAL OF IMPLANTS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Sepsis

  MAUDE report 23634700 ↗
• InjuryNov 19, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT TRIPPED ON A MAT IN HER KITCHEN AND FELL ON HER RIGHT SIDE. AFFECTED SIDE-RIGHT SIDE.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 23597354 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: 17 OCT 2025 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: LEFT. TREATMENT/IMPACT: COMPONENTS REMOVED (STEM, HEAD, LINER, SHELL) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 121722058 LOT NUMBER: M9551X COMPONENT TYPE: SHELL DESCRIPTION: PINNACLE SHELL SECTOR 58MM. CATALOG NUMBER: 136540730 LOT NUMBER: 4549269 COMPONENT TYPE: HEAD DESCRIPTION: BIOLOX DELTA REVISION HEAD 12/14 40MM +8.5. CATALOG NUMBER: 101012070 LOT NUMBER: 4724370 COMPONENT TYPE: STEM DESCRIPTION: ACTIS COLLARED HIGH OFFSET FEMORAL STEM SZ 7. CATALOG NUMBER: 122140058 LOT NUMBER: M9976F COMPONENT TYPE: LINER DESCRIPTION: PINNACLE ALTRX 58MM X 40MM NEUTRAL. CATALOG NUMBER: 121730500 LOT NUMBER: PU236738 COMPONENT TYPE: SCREW DESCRIPTION: CANCELLOUS BONE SCREW 30MM.

  Patient problems: Unspecified Infection

  MAUDE report 23533611 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, ALL IMPLANTS WERE EXTRACTED AND ANTIBIOTIC BEADS WERE IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22686915 ↗
• MalfunctionJul 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WASN'T SEALED ON THE INSIDE. DOE: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649114 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22336804 ↗
• InjuryApr 21, 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. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21872080 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 21635270 ↗
• InjuryJan 30, 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 INSTABILITY. THERE WAS NO SURGICAL DELAY.AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21275567 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SUBCUTANEOUS INFECTION. HEAD, LINER, STEM WERE REMOVED. THERE WAS NO DELAY IN CASE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21091533 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO DELAY. THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Fall; Limb Fracture

  MAUDE report 19277233 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO PERIPROSTHETIC FEMUR FRACTURE. NO DELAYS IN SURGERY, NO BROKEN INSTRUMENTS WAS REPORTED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 19164743 ↗
• InjuryMar 25, 2024Fracture; Fracture

  FRACTURE OF AN ACTIS PROSTHETIC NECK; ALSO AN FRACTURE OF THE CERAMIC INSERT; IMPLANTATION: 2019 1ST REVISION WAS AT THE YEAR 2021. REASON: FIRST FRACTURE OF THE CERAMIC INSERT. AGAIN IMPLANTATION OF AN CERAMIC INSERT AND ALSO THE CERAMIC HEAD WAS CHANGED; 2ND REVISION WAS (B)(6) 2024 - AGAIN FRACTURE OF THE CERAMIC INSERT AND ALSO THE ACTIS NECK BROKE.

  Patient problems: Insufficient Information

  MAUDE report 18969819 ↗
• MalfunctionOct 18, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  CUSTOMER IS COMPLAINING THAT THE PRODUCT'S STERILE PACKAGING OF THE STEM IS ALSO SHRINK-WRAPPED IN THE PLASTIC PACKAGING, WHICH MAKES CORRECT OPENING IMPOSSIBLE. THERE WAS A FEMORAL SOCKET WITH THE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956918 ↗
• MalfunctionAug 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON PLACED THE HEAD ONTO THE STEM AND AFTER IMPACTING, THE STEM CAME OUT. THE SURGEON TOOK X-RAYS TO CONFIRM THAT THE FEMUR WAS NOT FRACTURED. A DIFFERENT SIZE IMPLANT WAS USED TO COMPLETE THE SURGERY. THE REMAINDER OF THE PROCEDURE RESUMED WITHOUT ANY INCIDENT. THE ISSUE IS BELIEVED TO BE WITH THE SIZE OF THE BROOCH USED TO CREATE THE CAVITY FOR STEM IMPLANTATION. BECAUSE THE STEM CAME OUT, ANOTHER SIZE BROOCH WAS USED, AND THE IMPLANTATION OF THE STEM WAS SUCCESSFUL. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. MEDICAL DEVICE REPORT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646338 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17226057 ↗
• InjuryMay 31, 2023Migration; Migration

  THE PATIENT WAS REVISED AS THE STEM SUBSIDED, HAD TO BE REMOVE IT AND REPLACE IT WITH A REVISION COMPONENT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17031374 ↗