ACTIS 101012040Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295380566), received between Jul 23, 2018 and Jun 10, 2026 — classified as 50 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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 58 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN OUT OF BED ON THE DAY OF SURGERY AND HAD FRACTURED THE FEMUR DOI-(B)(6) 2026. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 25456981 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THA FOR FEMORAL NECK FRACTURES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2026, THE SURGEON DETERMINED THAT THERE WAS A POSTOPERATIVE INFECTION, AND DEBRIDEMENT WAS PERFORMED ON THE SAME DAY. THE LINER AND HEAD WERE REPLACED AS THE SLIDING SURFACE AND THE INFECTION SITE WAS THOROUGHLY CLEANSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. IMPLANT DATE: (B)(6) 2025. EXPLANT DATE:(B)(6) 2026 (ONLY THE LINER AND HEAD WERE REPLACED).

  Patient problems: Unspecified Infection

  MAUDE report 24885131 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AFTER SURGERY, STEM AND HEAD WERE EXPLANTED. NO DELAY IN CASE, NO HARM TO THE PATIENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fall

  MAUDE report 24496519 ↗
• InjuryDec 4, 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 INITIAL STEM PERFORATED FEMORAL CORTEX SO REVISED TO LONGER STEM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 23715888 ↗
• InjuryNov 25, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE WAS REVISION OF ACTIS STEM FOR SUBSIDENCE. INFECTION SUSPECTED, BUT ASPIRATION WAS NEGATIVE AT THE TIME OF THE REVISION SURGERY. THE CUP WAS RETAINED. THE ORIGINAL LINER WAS REPLACED. FEMORAL STEM WAS LOOSE AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23646140 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM SAINT VINCENT HOSPITAL AND HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER 73, 83-YEAR-OLD FEMALE. PATIENT EXPERIENCED AN INTRAOPERATIVE GREATER TROCHANTER FRACTURE REQUIRING SURGICAL INTERVENTION OF PLATING AND CABLES. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Limb Fracture

  MAUDE report 23525823 ↗
• MalfunctionJul 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PATIENT WAS PLANNED FOR TOTAL HIP REPLACEMENT. THE OUTER STERILITY PACKET FOR THE STEM SEEMED TO BE COMPROMISED BECAUSE AIR WAS PRESENT. NOT KNOWN IF INNER/FINAL AIR LOCK WAS COMPROMISED. HAD A SECOND STEM ON HAND THAT SURGEON PREFERRED TO USE. OTHER THAN THE BOX, NOTHING WAS OPENED OR ATTEMPTED TO BE OPENED. BOX AND SHRINK WRAP WERE FULLY IN TACT. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591854 ↗
• InjuryJul 16, 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 INFECTED HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22522116 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURED THE FEMUR AFTER ORIGINAL TOTAL HIP. STEM AND HEAD WAS REMOVED ALONG WITH POLY LINER AND THE FEMUR WAS REPAIRED. THERE WAS NO DELAY OR COMPLAINTS. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 21959830 ↗
• InjuryApr 22, 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 PERIPROSTHETIC FRACTURE. SURGEON PULLED STEM AND HEAD. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 21882953 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN , DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21379834 ↗
• InjuryJan 8, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN. ALSO, THERE WAS NON-CEMENTED LOOSENING OF THE FEMORAL STEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21105151 ↗
• 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 PERIPROSTHETIC FRACTURE. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Limb Fracture

  MAUDE report 21073929 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED JOINT. THERE WAS NON-CEMENTED LOOSENING OF THE CUP, SUSPECTED FROM LYSIS AND INFECTION. EVERYTHING WAS EXPLANTED AND A SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT HIP.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20676950 ↗
• InjuryOct 14, 2024Naturally Worn; Naturally Worn

  SQUEAKING DU TO CERAMIC INSERT FRACTURE. 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 --> , WAS DEVICE EXPLANTED? --> TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: --> CERAMIC INSERT FRACTURE, DID PATIENT REQUIRE REVISION SURGERY? --> TRUE, IF YES, DATE OF REVISION SURGERY. -->(B)(6) 2024, REASON FOR REVISION SURGERY. --> CERAMIC INSERT FRACTURE, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> SQUEAKING, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> YES, IF YES, DESCRIBE --> X-RAY, ACETABULAR REVISION, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS

  Patient problems: Insufficient Information

  MAUDE report 20439206 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PERIPROSTHETIC FRACTURE. ORIGINAL LEFT HIP PROCEDURE AND IMPLANT COMPLETED ON (B)(6) 2024.

  Patient problems: Limb Fracture

  MAUDE report 20294422 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT ON (B)(6) 2024. THE PATIENT UNDERWENT A SURGERY VIA THA TREATING THE RIGHT HIP. AFTER THE SURGERY, A FRACTURE OCCURRED. THE FRACTURE OCCURRED, DUE TO THE CRACK THAT HAD BEEN PRESENT/OBSERVED JUST BELOW THE LESSER TROCHANTER, DURING THE INITIAL SURGERY ON (B)(6). ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, THE STEM WAS REMOVED AND REPLACED WITH AN AMT HIGH OFFSET LONG 2. TWO CABLES WERE TIED AROUND THE AFFECTED AREA. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Limb Fracture

  MAUDE report 20199131 ↗
• InjuryAug 15, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO STEM LOOSENING DUE TO PERIPROSTHETIC FEMUR FRACTURE. DOI: (B)(6), DOR: UNKNOWN, AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 19989912 ↗
• InjuryAug 9, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S ACTIS STEM SUBSIDED OVER TIME. SURGEON REMOVED ACTIS STEM AND CERAMIC FEMORAL HEAD. SURGEON PREPARED AND IMPLANTED A RECLAIM STEM AND NEW FEMORAL HEAD. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19948796 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO TROCHANTER FRACTURE RIGHT HIP AND HIP WAS DISLOCATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 19164314 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED BECAUSE OF PERIPROSTHETIC FRACTURE. NO DELAYS NO HARM TO PATIENT. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Limb Fracture

  MAUDE report 18452835 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18435732 ↗
• MalfunctionDec 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON BROACHED WITH KINICISE UP TO A SIZE 4 ACTIS BROACH. PER SUREGON, BROACH WAS ROTATIONALLY STABLE. HIP WAS TRIALED AND WHEN THE SIZE 4 STEM WAS IMPLANTED IT WAS NOTED THE SURGEON TO BE LOOSE AND UNDERSIZED. THE STEM WAS REMOVED. AND THE SURGEON BROACHED TO A SIZE 5 AND IMPLANTED A SIZE 5 ACTIS STEM WITH GOOD FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400229 ↗
• InjuryNov 8, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST OP AND DISLOCATED. STEM WAS SWAPPED FOR CEMENTED CONSTRUCT SINCE THE FALL LOOSENED THE STEM SHORTLY AFTER SURGERY. THE LOOSENING INTERFACE OF STEM IS NON-CEMENTED, CEMENT MANUFACTURER IS UNKNOWN. CONSTRAINED TOTAL HIP WAS IMPLANTED TO AVOID FUTURE DISLOCATIONS. NOTHING FURTHER TO REPORT. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 18094481 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A FALL AND NEEDED TO BE REVISED TO A CORAIL REVISION STEM. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall

  MAUDE report 18074413 ↗