ACTIS 101012010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295380535), received between Aug 29, 2018 and Dec 12, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2024 FOR A FRACTURED HIP. ACTIS AND HEADBALL WERE IMPLANTED. THE PATIENT WENT HOME AND FELL AND BROKE THEIR FEMUR AROUND THE STEM AND IT WAS REVISED ON (B)(6) 2024. THERE WAS NO DELAY IN SURGERY, NO ADVERSE SYMPTOMS THAT LED TO REVISION SURGERY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 20915983 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SURGERY IS THIS PATIENT'S SECOND HIP REVISION SURGERY IN THE PAST NINE DAYS DUE TO INFECTION. DURING HER FIRST REVISION SURGERY, PERFORMED ON (B)(6), 2023, HER PRIMARY FEMORAL HEAD AND POLYETHYLENE LINER WERE REMOVED, AND HER HIP WAS THOROUGHLY IRRIGATED AND DEBRIDED. A REPLACEMENT FEMORAL HEAD AND A REPLACEMENT POLYETHYLENE LINER WERE THEN IMPLANTED. THIS MOST RECENT SURGERY WAS THE FIRST STAGE OF A TWO-STAGE REVISION PROCEDURE DUE TO THE SAME INFECTION. DURING THIS SURGERY, ALL OF THE PATIENT'S COMPONENTS WERE REMOVED. HER HIP WAS ONCE AGAIN THOROUGHLY IRRIGATED AND DEBRIDED. AN ANTIBIOTIC SPACER CONSTRUCT, WHICH INCLUDED A PROSTALAC CUP, STEM, AND FEMORAL HEAD, WAS THEN IMPLANTED. THERE WAS NO SURGICAL DELAY. DURING THE SECOND STAGE OF THE TWO-STAGE PROCEDURE, WHICH WILL OCCUR ONCE THE PATIENT IS INFECTION FREE, THE ANTIBIOTIC SPACER WILL BE REMOVED AND REPLACED BY FINAL HIP REVISION COMPONENTS. DOI(FOR CUP AND STEM): (B)(6), 2023, DOI(FOR LINER AND HEAD): (B)(6), 2023, DOR: (B)(6), 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17948386 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 17867690 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE PRIMARY SURGERY EARLIER IN THE WEEK DONE BY SURGEON AT (B)(6). PATIENT FELL A FEW DAYS LATER AND FRACTURED HER FEMUR. SURGEON REMOVED THE ACTIS STEM AND IMPLANTED A RESTORATION STEM WITH A FEW CABLES. HE ALSO REMOVED THE 32MM LIPPED LINER AND REPLACED IT WITH A 36MM NEUTRAL LINER. DOI: UNKNOWN; DOR: (B)(6) 2020 (LEFT HIP).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9602251 ↗
• MalfunctionAug 29, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON BROACHED THE PATIENT'S FEMUR TO A SIZE #1. WHEN THE ACTIS #1 STEM WAS INSERTED INTO THE FEMUR IT WAS DEEMED TO BE TOO LOOSE TO ACCEPT. THE SURGEON ELECTED TO BROACH UP TO A SIZE #2. THE #2 ACTIS WAS INSERTED AND CONSIDERED BE A GOOD FIT. THE SIZE #1 WAS EXPLANTED. IT WAS ALSO REPORTED THAT THERE WAS NON-CEMENTED INTERFACE. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES. DOE: (B)(6) 2018; (LEFT HIP).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7826179 ↗