ACTIS 101011020Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295380429), received between Sep 28, 2018 and Apr 27, 2026 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A LEFT TOTAL HIP DONE BY SURGEON IN (B)(6) 2024. PATIENT CAME IN WITH A HIP INFECTION AND REMOVAL OF IMPLANTS AND ANTIBIOTIC SPACER WAS IMPLANTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24999780 ↗
• MalfunctionFeb 26, 2026Device-Device Incompatibility; Difficult to Advance

  ADDITIONAL INFORMATION RECEIVED STATES THAT REAMING AND BROACHING WAS PERFORMED WITH THE PROPER ACTIS INSTRUMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455505 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERI PROSTHETIC WAS FRACTURED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24078686 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD NATIVE INFECTED HIP. A SPACER WAS PLACED TO TREAT INFECTION. PATIENT WAS INFECTED AGAIN SO THE SPACER WAS REMOVED ON (B)(6) 2025. A NEW SPACER WAS PLACED ON THIS DATE. AFFECTED SIDE-UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24034955 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A FALL AND SUFFERED A PERI PROSTHETIC FRACTURE. SURGEON REPAIRED IT WITH RECLAIM MONO BLOCK STEM. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22559802 ↗
• 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 INFECTED SO THE SURGEON TOOK ALL COMPONENTS OUT AND PUT AN ANTIBIOTIC SPACER IN. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21687035 ↗
• MalfunctionNov 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A THA WITH ACTIS FOR HIP JOINT. THE RASP WAS INSERTED INTO THE FEMUR TO FORM A SPACE FOR THE STEM. THE SURGEON AND THE NURSES CHECKED THE SIZE OF THE STEM, AND THE NURSE OPENED THE PACKAGE OF THE STEM. WHEN THE STEM WAS INSERTED, IT CONSIDERABLY FLOATED. THE SURGEON CHECKED THE SIZE, AND IT WAS FOUND THAT THE RASP HAD BEEN DEPLOYED TO SIZE 1, AND THE SIZE OF THE NECK TRIAL HAD BEEN 2/3. THE SIZE OF THE REAL STEM WAS SIZE 2.THE SURGEON DECIDED TO REMOVE THE STEM ONCE, AND THE RASP WAS DEPLOYED TO SIZE 2. SUBSEQUENTLY, THE STEM WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734319 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE FROM INFECTION, STEM CAME OUT WITH IMPLANT REMOVAL. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20615705 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD (B)(6) 2023 PERTAINING TO NON MOM CONSTRUCT WAS REVIEWED BY CLINICIAN. (B)(6) 2023 MRI DEMONSTRATES RIGHT HIP ARTHROPLASTY, MILD INCREASED SIGNAL ON FLUID SENSITIVE SEQUENCES ALONG THE FEMORAL STEM. MODERATE RIGHT GREATER TROCHANTERIC BURSITIS VERSUS HEMATOMA/SEROMA. THE PATIENT ALSO REPORTED HAVING WEAKNESS AND PAIN. THE IMPRESSION IS MILD TROCHANTERIC BURSITIS. ILIOPSOAS TENDINITIS APPEARS TO BE FROM PROMINENCE OF THE IRRITATING PSOAS TENDON ITSELF. CORTICOSTEROID INJECTION IS RECOMMENDED. DOI: (B)(6) 2022 ( STEM). DOI: (B)(6) 2023 (LINER, HEAD). DOE:(B)(6) 2023. RIGHT HIP.

  Patient problems: Fatigue; Hematoma; Inflammation; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 18442485 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CONCERN WITH A HIP REPLACEMENT AND LATER, DEVELOPED A POSTERIOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17623700 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE . DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 17342630 ↗
• InjuryOct 20, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSE ACTIS FEMORAL STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15638322 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE ACETABULAR CUP AT THE BONE TO IMPLANT INTERFACE. SURGEON BELIEVES INFECTION WAS PRESENT. ALL COMPONENTS WERE REMOVED, AND A ONE STAGE TOTAL HIP REVISION WAS PERFORMED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13175215 ↗
• MalfunctionMay 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSERTER GOT STUCK IN THE IMPLANT. IMPLANT WAS IMPLANTED AND THEN REMOVED. IT WAS INDICATED THAT THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 11808695 ↗
• InjuryMar 22, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGEON SUSPECTED INFECTION AND TOOK BIOPSIES DURING THE REVISION. BIOPSY RESULTS REVEALED THAT THE PATIENT HAD BONE CANCER, NOT AN INFECTION. THE FEMORAL COMPONENT WAS LOOSE.

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

  MAUDE report 11543448 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED GRAM NEGATIVE BACTERIAL INFECTION. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER IMPLANTED. ENCLOSED IS ALL THE INFO I HAVE FOR THIS PATIENT. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10684080 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FEMUR FRACTURE. CHANGED STEM AND HEAD FOR LONGER STEM. DOI: (B)(6) 2019; DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9708654 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9198927 ↗
• InjuryApr 30, 2019Loss of Osseointegration; Device-Device Incompatibility; Unintended Movement; Loss of Osseointegration; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FEMORAL COMPONENT LOOSENING AT THE BONE TO IMPLANT INTERFACE. THE ACTIS STEM APPEARED TO BE UNDERSIZED AND COLLAPSED INTO VARUS. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8564629 ↗
• InjurySep 28, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENTS ACTIS STEM WAS UNSTABLE AND LOOSENED AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 7920518 ↗