ACTIS 101011070Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295380474), received between Oct 3, 2018 and Sep 24, 2026 — classified as 42 injuries, 2 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 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to suspected infection.DOI: (b)(6) 2026,DOR: (b)(6) 2026,Affected side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50883165 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fall; Limb Fracture

  MAUDE report 50739185 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the doctor did a LTH on this patient utilizing standard technique. Upon arriving in the recovery room, x-rays were taken. The next day, the patient had a fracture of the greater trochanter. The partner and on call Surgeon, decided to revise the hip. All components were revised. It was stated that the Femoral stem, head, cup, insert and screws were loose. Loosening interface was marked as bone to implant.DOI: (b)(6)2026DOR: (b)(6) 2026Affected side: Left hip

  Patient problems: Limb Fracture

  MAUDE report 50098176 ↗
• InjuryMay 13, 2026Osseointegration Problem; Migration

  IT WAS REPORTED THE PATIENT HAD A TOTAL HIP PERFORMED. POST-OPERATIVELY DURING RECOVERY THE PATIENT DISLOCATED THEIR HIP WHEN MOVED TO ANOTHER BED. AFTER AN X-RAY WAS TAKEN, IT WAS FOUND TO HAVE A FX AND SUBSEQUENT STEM SUBSIDENCE. DR. BROUGHT THE PATIENT BACK TO SURGERY AND REVISED HIM TO A LARGER STEM. HE ALSO HAD TO USE A LONGER HEAD. THE PATIENT WAS CLOSED IN THE USUAL FASHION. THE LOOSENING WAS FOUND TO BE NON-CEMENTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 25159167 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT SURGERY WITH ACTIS IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IN (B)(6) 2026, A PERIPROSTHETIC FRACTURE OCCURRED DUE TO TRAUMA. REVISION SURGERY WAS PERFORMED, AND SINCE THE STEM WAS STABLE UPON EXTRACTION TESTING, ONLY THE HEAD AND BIPOLAR CUP WERE REPLACED, FOLLOWED BY OSTEOSYNTHESIS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THIS PC REPORTS REVISION SURGERY. THIS PC IS RELATED TO (B)(4) WHICH REPORTS A PERISTOME FRACTURE AFTER THE PRIMARY SURGERY.

  Patient problems: Limb Fracture

  MAUDE report 24801914 ↗
• InjuryMar 11, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMI IMPLANTED ABOUT A MONTH PRIOR. PATIENT FELL AGAIN AND FRACTURED THEIR FEMUR. SURGEON REMOVED ALL THE HEMI COMPONENTS AND REPLACED WITH RECLAIM MODULAR REVISION STEM AND NEW BIPOLAR HEAD. IT WAS STATED THAT THE FEMORAL STEM WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 24576033 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR INFECTION AND PAIN. THE ARTICULAR SURFACE OF THE CERAMIC FEMORAL HEAD SHOWS MINOR METAL TRANSFER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23933700 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IMPLANTS WERE EXTRACTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23908806 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TAKEN BACK TO SURGERY FOR SUSPECTED INFECTION. THE DOCTOR ELECTED TO REMOVE ALL THE IMPLANTS AND REVISE. EVERYTHING WAS REMOVED WITHOUT ISSUE AND NEW IMPLANTS WERE USED ONCE THE PATIENT WAS WASHED OUT. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23741760 ↗
• InjuryDec 2, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 23696826 ↗
• InjuryOct 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 INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23424197 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PERIPROSTHETIC FRACTURE FROM FALLING. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22678591 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK TO THE HOSPITAL WITH DRAINING FROM HER TOTAL HIP DONE ONE WEEK AGO. DOCTOR BELIEVED THE JOINT TO BE INFECTED AND PLANNED TO WASH THE JOINT OUT, PLACE ANTIBIOTICS AND SWAP THE POLY AND HEAD WITH THE SAME IMPLANTS. WHILE REMOVING THE FEMORAL HEAD, THE STEM CAME OUT AS WELL. DOCTOR DECIDED TO REMOVE ALL IMPLANTS. DOCTOR USED A COMPETITOR CUP/LINER AND RE-IMPLANTED AN ACTIS AND CERAMIC HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 21873311 ↗
• MalfunctionMar 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT HAIR WAS FOUND INSIDE STERILE PACKAGING. THERE WAS ONLY COUPLE OF MINUTES DELAY TO GET ANOTHER IMPLANT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559925 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A TOTAL HIP ON (B)(6) 2024. PATIENT BECAME INFECTED AND HAD A HEAD & LINER EXCHANGE ON (B)(6) 2025. PATIENT RETURNED WITH ANOTHER INFECTION FOR A FULL REVISION. NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES AFFECTING THE PATIENT BECAUSE OF THE REPORTED EVENT. NO FURTHER INFORMATION WAS PROVIDED FOR REPORTING. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21552745 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY. IT WAS FURTHER REPORTED THAT INFECTION WAS UNABLE TO BE DETERMINED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21524798 ↗
• InjuryDec 26, 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 INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21021018 ↗
• InjuryDec 11, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: --SURGICAL DELAY INVOLVED REMOVING THE STEM AND IMPLANTING A CORAIL REVISION STEM. -THE LINER WAS NOT DEPUY. -PATIENT WAS INFECTED. - NO ALLEGATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20903013 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE IMPLANTS WERE REMOVED, DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20869462 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT CONSEQUENCES. THE AFFECTED SIDE WAS THE LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20578330 ↗
• MalfunctionJul 26, 2024Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS STERILE PLASTIC PACKAGING AROUND IMPLANT CONTAINED A SIZABLE HOLE AND CRACK IN CAUSING STERILITY TO BE QUESTIONED. THERE WAS NO DAMAGE TO THE BOX THAT THE IMPLANT CAME IN. THE NURSE DID NOT MISHANDLE THE PACKAGING. IT WAS NOTICED BEFORE TRANSFER TO STERILE FIELD. DUE TO QUESTION OF STERILITY OF PACKAGING, IMPLANT WAS NOT USED AND A DIFFERENT IMPLANT WAS OPENED. DOE: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Insufficient Information

  MAUDE report 19837280 ↗
• InjuryJul 2, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A SUCCESSFUL THA PERFORMED ON (B)(6) 2024 PATIENT SUSTAINED FRACTURE ON FLOOR. REVISED NEXT DAY COMPLEX SPIRAL PERIPROSTHETIC FRACTURE. FRACTURE WAS REDUCED WITH CABLES. ACTIS REMOVED AND TO BYPASS FRACTURE SITE AND GAIN STABILITY RECLAIM STEM USED AFTER A READJUSTMENT FOR ANTE VERSION -WELL FIT STEM WAS USED WITH DUAL MOBILITY PINNACLE LINER. STABLE CONSTRUCT. FILMS LOOKED VERY WELL REDUCED FRACTURE SITES AND SEGMENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 19657558 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. IT DID NOT HAPPEN IN SURGERY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18763337 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A HEMI HIP BACK IN (B)(6) OF 2023. PATIENT RECENTLY FELL AND FRACTURED THE LEFT HIP AROUND THE STEM. SURGEON PULLED THE UNIPOLAR HEAD, TAPER SPACER AND STEM OUT AND REPLACED WITH A LONG STEM, HEMI HEAD W/ PLATE AND CABLES. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18041214 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NON-UNION OF MID-SHAFT FEMORAL FRACTURE, JUST DISTAL TO STEM. SURGEON WANTED TO REVISE WITH A LONGER STEM TO BYPASS FRACTURE SITE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO ADDITIONAL INFORMATION. DOI- (B)(6) 2013, DOR- (B)(6) 2023, AFFECTED SIDE- LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17584940 ↗