ACTIS 101012020Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295380542), received between Sep 21, 2018 and May 13, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS LOOSENING OF STEM AT UNKNOWN INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22009637 ↗
• InjuryMar 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 FOR INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21698640 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF A RIGHT TOTAL HIP FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21150621 ↗
• InjuryNov 15, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18144109 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL HIP. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14597748 ↗
• InjuryOct 8, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO GROIN/THIGH PAIN AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12599556 ↗
• InjurySep 29, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL HIP PROCEDURE DONE ON (B)(6) 2021. THE PATIENT WAS DEALING WITH SOME DISCOMFORT OF THEIR LEFT HIP. UPON VIEWING X-RAYS, THE SURGEON BELIEVED THE STEM HAD COME LOOSE AND OPTED TO REVISE THE FEMORAL COMPONENT. IT WAS CONFIRMED THAT THE STEM WAS IN FACT LOOSE AND THE SURGEON WAS ABLE TO REMOVE WITH THE THREADED HANDLE AND SLAP HAMMER. THE SURGEON ALSO WANTED TO REMOVE THE 52 X 32 LIPPED LINER THAT THE SURGEON HAD IMPLANTED AND EXCHANGE IT FOR A 52 X 36 NEUTRAL LINER. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM IMPLANTING THE COMPETITOR. DOI: (B)(6) 2021. DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Inadequate Osseointegration

  MAUDE report 12546478 ↗
• InjuryJul 27, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT DISLOCATED WITHIN A COUPLE DAYS OF INDEX SURGERY. WE WENT BACK IN AND REVISED THE STEM, CHANGING THE VERSION. WE ALSO WENT FROM A NEUTRAL LINER TO A + 4 10 DEG TO HELP WITH STABILITY. THE CUP HAD APPROPRIATE VERSION AND INCLINATION SO WE CHOSE TO RETAIN ORIGINAL CUP. STEM WAS LOOSE AND HAD TURNED WHICH CHANGED VERSION. PATIENT WAS STABLE AFTER NEW IMPLANTS WERE INSERTED. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (UNKNOWN SIDE).

  Patient problems: Inadequate Osseointegration

  MAUDE report 12235391 ↗
• MalfunctionJan 29, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  DURING SURGERY AFTER THE SURGEON PREPPED THE FEMUR FOR AN ACTIS STEM A SIZE 2HI WAS REMOVED FROM ITS BOX THEN HANDED TO CIRCULATING NURSE WHO OPENED THE PACKAGING TO ALLOW FOR THE SCRUB NURSE TO SAFELY TAKE. UPON REMOVING THE STEM FROM ITS STERILE PACKAGING A HAIR WAS FOUND ON THE BLUE ENVELOPE OF THE STEM. SURGEON DEEMED THE IMPLANT UNSAFE TO USE FOR THE PATIENT AND A SECOND STEM WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 11251319 ↗
• InjuryDec 17, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND RESULTED IN A PROXIMAL FEMORAL FRACTURE THAT REQUIRED REVISION OF THE FEMORAL STEM AND HIP BALL. IT WAS ALSO INDICATED THAT THERE WAS A LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT HIP.

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

  MAUDE report 11028362 ↗
• InjurySep 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE. IT WAS ALSO INDICATED THAT THE STEM WAS UNDERSIZED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7897969 ↗