ACTIS 101012080Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295380603), received between Aug 8, 2017 and Jun 15, 2026 — classified as 25 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD FALLEN AND OPENED UP IN THE INCISION, SO DOCTOR WANTED TO EXCHANGE COMPONENTS. THE ORIGINAL SURGERY HAD BEEN DONE TWO WEEKS EARLIER. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 25502848 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. REMOVAL OF IMPLANTS LISTED. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24956289 ↗
• MalfunctionFeb 27, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE ACTIS STEM, THE INTERNAL PACKAGE HAD A CRACK AND STERILITY SEEMED COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470657 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISLOCATION AND FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24069095 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME INFECTED ABOUT 4 WEEKS POST OP. DOCTOR OPTED TO PULL HARDWARE, RUN LABS AND USE AND MEDICATED TEMP SPACER. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23888226 ↗
• InjuryDec 1, 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 FEMUR FRACTURE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 23679485 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23058390 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ORIGINAL SURGERY HAD AN ACTIS STEM, EMPHASYS CUP, EMPHASYS LINER, AND 40 MM HEAD. ALL THESE PARTS WERE REMOVED BY THE DOCTOR IRRIGATED AND DERIDED THEN RE-PREPPED AND IMPLANTED AN ACTIS COLLARLESS SIZE 9 HIGH STEM, 58 MM EMPHASYS CUP, 40 MM 58 MM EMPHASYS, NEUTRAL LINER, AND A 40 MM +5 FEMORAL HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22981927 ↗
• MalfunctionJul 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ON (B)(6) 2025. DURING THE PROCEDURE, THE 8 HIGH OFFSET STEM WAS OPEN AND ONE OF THE INNER PACKAGES WAS NEVER SEALED OR STERILIZED. IT COULD BE SEEN ON THE PACKAGE THAT ONE SIDE WAS NEVER "PRESSED CLOSED;" IT WAS JUST LEFT WIDE OPEN. THE STEM DID NOT ENTER THE STERILE FIELD. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439269 ↗
• InjuryJul 1, 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 LEFT HIP. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22375627 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FELL AND FRACTURED HIS HIP BELOW THE STEM AND DUAL MOBILITY LINER WAS ALSO LOOSE. DOCTOR WANTED TO REVISE TO A REVISION STEM AND DUAL MOBILITY COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22151421 ↗
• 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 FOR PERIPROSTHETIC FRACTURE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 21880492 ↗
• MalfunctionNov 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INTRAOPERATIVELY ON (B)(6) 2024, DURING IMPACTION OF AN ACTIS STEM THE IMPACTION INSTRUMENT´S THREAD FRACTURED. THE INSTRUMENT FRACTURED INTO TWO PARTS. THE FRAGMENT REMAINED INSIDE THE STEM´S HOLE. ANOTHER STEM AND ANOTHER IMPACTOR WERE USED WITHOUT ISSUES. THERE WAS 10 MINUTES SURGICAL DELAY. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725166 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ACTIVE INFECTION. SURGEON DECIDED TO DO SINGLE STAGE REVISION WITH HIP IRRIGATION AND DEBRIDEMENT (I&D). IMPLANTS WERE REMOVED AND AFTER EXTENSIVE I&D, NEW IMPLANTS PLACED IN AGAIN. EXPLANTS ARE UNAVAILABLE FOR RETURN, THERE WAS NO DELAY IN PROCEDURE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19974394 ↗
• InjuryAug 8, 2024Adverse 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 REMOVED AND A TEMPORARY SPACER WAS PLACED. DOI: ON (B)(6) 2024 . DOR: ON (B)(6) 2024 . AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19944467 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP

  Patient problems: Limb Fracture

  MAUDE report 19126895 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SURGEON THAT THERE WAS A MISMATCH BETWEEN OUR BROACH TO IMPLANT SIZES. PARTS WERE SENT IN AND INSPECTED. UNKNOWN SURGICAL DELAY. DOE: (B)(6). AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17905503 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AND BROKE HIS PROXIMAL FEMUR. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 17867485 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17833843 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17825687 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO AN INFECTION. PRODUCTS WERE EXPLANTED AND A SPACER WAS PUT IN. DOI- (B)(6) 2023. DOR- (B)(6), 2023.

  Patient problems: Unspecified Infection

  MAUDE report 17599101 ↗
• MalfunctionJun 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS RESIDUE ON THE TRUNNION OF THE STEM. THE SURGEON SAID IT LOOK LIKE "A DROP OF ICING". DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210197 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17180893 ↗
• MalfunctionApr 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AT THE TIME OF IMPLANTING ACTIS STEM, IT WAS REMOVED FROM THE PROTECTIVE PACKAGING AND THE SURGEON NOTICED A VISUAL DEFECT (MARKING) ON THE HA COATING. IT WAS NOT BLOOD OR ANYTHING FROM THE STERILE FIELD. THIS HAS NEVER BEEN SEEN BEFORE SO THE DECISION WAS MADE TO OPEN A 2ND STEM AND COMPLETE THE PROCEDURE. THIS CAUSED A 5 MINUTE DELAY. DATE OF EVENT WAS (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741868 ↗
• MalfunctionMar 20, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE STERILE BLUE ENVELOPE THAT CONTAINS THE ACTIS STEM SURGEON SAW THERE WAS STRANDS OF LINT ON THE UNDER SIDE OF THE COLLAR. SURGEON REMOVED THEM WITH A PICK UP. UPON FURTHER INSPECTION SURGEON SAW MORE NEAR THE SHOULDER OF THE IMPLANT. SURGEON WAS UNCOMFORTABLE IMPLANTING THAT STEM SO SALES REPRESENTATIVE PROVIDED SURGEON WITH THE SAME SIZE STEM AND THAT WAS THEN IMPLANTED IN THE PATIENT. SALES REPRESENTATIVE WAS THERE TO WATCH THE STEM COME OUT OF THE STERILE BLUE ENVELOPE WITH THE DESCRIBED LINT AND ALSO TOOK A PICTURE OF THE LINT ON THE SHOULDER AS THE SURGEON HAD ALREADY REMOVED THE LINT FOUND ON THE UNDER SIDE OF THE COLLAR. THERE WAS A SURGICAL DELAY OF 2 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16571951 ↗