ACTIS 101011080Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295380481), received between Jun 18, 2018 and Dec 9, 2025 — classified as 27 injuries, 8 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, THE HEAD BALL WAS SCRATCHED DUE TO THE IMPACTOR TIP BREAKING AND SO THE SURGEON WANTED A NEW ONE. WHEN THE SURGEON ATTEMPTED TO KNOCK THE HEAD OFF THE STEM TO REPLACE, SURGEON COULD NOT GET THE HEAD TO DISASSOCIATE FROM THE STEM AND THE ENTIRE PROSTHESIS CAME OUT. THE SURGEON HAD TO INSERT A NEW STEM BECAUSE THE SURGEON WAS UNABLE TO SEPARATE THE TWO IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759928 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ACUTE HIP INFECTION AND SURGEON DECIDED TO PERFORM SINGLE STAGE REVISION. ALL IMPLANTS WERE REMOVED AND HIP I&D DONE. THERE WERE NO COMPLAINTS OR DELAYS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22499665 ↗
• InjuryJul 10, 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 PERI PROSTHETIC FRACTURE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 22470094 ↗
• InjuryJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT STOOD UP FOR FIRST TIME IN PACU AND EXPERIENCED A POP AND PAIN. UPON GETTING AN XRAY, IT WAS FOUND THAT THE HEAD BALL HAD DISLODGED FROM THE NECK TRUNION OF THE STEM. THE HEAD WAS RETAINED IN THE CUP, BUT THE STEM DISLOCATED FROM THE HEAD AND OUT OF PLACE. THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 22166271 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL AND FRACTURED FEMUR JUST BELOW THE STEM. SURGEON REMOVED THE IMPLANTS AND ADDED CABLES TO THE FEMUR FOR STABILIZATION. SURGEON IMPLANTED A CORAIL REVISION STEM AND PUT A NEW BIPOLAR HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 21988485 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED THEIR FEMUR. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 20820668 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RIGHT HIP WAS REVISED ON (B)(6) 2024 DUE TO INFECTED HIP. ONE STAGE WASHOUT/REVISION PERFORMED. SURGICAL DELAY UNKNOWN. DATE OF IMPLANT (B)(6) 2024. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20777541 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ITEMS EXPLANTED DUE TO WOUND DRAINAGE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fluid Discharge

  MAUDE report 20725981 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED THE IMPLANTS DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20271352 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP. IMPLANTS WERE REMOVED AND SPACER IMPLANTED. THERE WERE NO ADVERSE EVENTS OR ISSUES WITH EXPLANTED PARTS. NO DELAY IN PROCEDURE. IMPLANTS ARE NOT AVAILABLE FOR RETURN. DOI: UNKNOWN . DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20181693 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURED FEMUR WHERE ACTIS STEM WAS PUT IN ON PRIMARY. SURGEON REMOVED STEM, HEAD, AND LINER. PUT IN A STRYKER REST MOD STEM, STRYKER HEAD WITH OUR DUAL MOBILITY LINER AND METAL SHELL SURGEON DID CABLES. DOI: (B)(6), 2022 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT FEMUR.

  Patient problems: Fall; Limb Fracture

  MAUDE report 20153469 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED AT OFFICE WITH HIP PAIN APPROX. 4 YEARS POST THA. LABS SHOWED AS ELEVATED. X-RAYS SHOWED A LUCENT LINE BEHIND ACETABULAR CUP. ASPIRATION WAS NEGATIVE BUT PAIN PERSISTED. PATIENT WAS SCHEDULED AND BROUGHT TO THE OR WITH SUSPECTED ASEPTIC LOOSENING OF ACETABULAR SHELL. GROSS PUSS WAS FOUND WHEN THE JOINT WAS OPENED AND ALL COMPONENTS WERE REMOVED. ALL COMPONENTS WERE WELL FIXED AND WELL FUNCTIONING AND NO ALLEGATION WAS MADE AGAINST ANY COMPONENT, THEY WERE REMOVED FOR INFECTION. NO DELAY NOR PATIENT HARM WAS NOTED. THE PATIENT WAS TREATED IN A ONE STAGE DUAL SETUP REVISION HIP ARTHROPLASTY WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS FOLLOWING AN EXTENSIVE IRRIGATION AND DEBRIDEMENT (I&D). UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2020. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20010293 ↗
• InjuryJan 8, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18463676 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. STEM AND HEAD WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18364308 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY FOR INFECTION S/P HIP HEMI. ALL OF THE IMPLANTS WERE REMOVED AND THE WOUND WAS DEBRIDED AND IRRIGATED. NEW IMPLANTS WERE PLACED. THERE WERE NO DEFICIENCIES, DELAYS OR BROKEN INSTRUMENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18364036 ↗
• InjuryNov 27, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY BECAUSE PATIENT'S STEM SUBSIDED ABOUT 1 CM. ACTIVITY LEVEL - YES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18209523 ↗
• MalfunctionNov 9, 2023Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN THE BOX FOR ACTIS 8 STD STEM WAS OPENED, IT WAS DISCOVERED THAT THE INNER PLASTIC CONTAINER WAS BROKEN AND CONTAMINATED THE IMPLANT. THE OUTER CARDBOARD BOX WAS NOT DAMAGED. THERE WAS NO PATIENT HARM, SINCE THE IMPLANT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102366 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT DID NOT DISSIPATE WITH ORIGINAL WASH OUT. CAUSE OF INFECTION WAS BELIEVED TO BE IMPROPER WOUND CARE AT THEIR NURSING HOME, AS THE PATIENT IS PRACTICALLY IMMOBILE AND OFTEN TIMES SITS IN SOILED GARMENTS FOR A PERIOD OF TIME. DOI: UNKNOWN. DOR: OCTOBER 22, 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Loss of Range of Motion; Unspecified Infection

  MAUDE report 18039114 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION WITH I&D ON (B)(6) 2023, DUE TO AN INFECTION. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17350972 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 16572356 ↗
• MalfunctionDec 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS IMPLANT DIDN'T SEAT PROPERLY. OPENED ANOTHER AND HAD APPROPRIATE FIT. POSSIBLE IMPLANT IS NOT A CORRECT SIZE. SURGICAL DELAY 10MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001144 ↗
• MalfunctionJul 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT POST REMOVAL OF AN UNCEMENTED STEM, IT BROACHED UP WITH THE ACTIS BROACHES, REACHED STABILITY AT SIZE 8 AND TRAILED OFF THAT WITH A STANDARD NECK. THE SURGEON THEN DECIDED TO DOWNSIZE TO A SIZE 7 BROACH. THERE WAS A SURGICAL DELAY OF 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231638 ↗
• MalfunctionJul 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT POST REMOVAL OF AN UNCEMENTED STEM, IT BROACHED UP WITH THE ACTIS BROACHES, REACHED STABILITY AT SIZE 8 AND TRIALLED OFF THAT WITH A STANDARD NECK. THE SURGEON THEN DECIDED TO DOWNSIZE TO A SIZE 7 BROACH. THERE WAS A SURGICAL DELAY OF 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231612 ↗
• MalfunctionJul 16, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE SURGEON STATES THAT THE 2 IMPLANTS WERE OUT OF SPEC. DOI: (B)(6) 2021: DOR: (B)(6) 2021: HIP UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12180692 ↗
• InjuryApr 21, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED AS ACTIS STEM, HEAD, BIPOLAR REVISED FOR PERIPROSTHETIC FRACTURE FOLLOWING PATIENT FALL. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 11699757 ↗