ACTIS 101011090Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295380498), received between Nov 29, 2018 and Apr 14, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Osseointegration Problem

  IT WAS REPORTED THAT REVISED DUE TO INFECTION. LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 24876237 ↗
• MalfunctionApr 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE STEM WAS NOT FITTING PROPERLY. THERE WAS NO SURGICAL DELAY OR PATIENT HARM. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21882923 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP PROSTHESES WERE REMOVED AND A PROSTALAC WAS PLACED UNEVENTFULLY AFTER A THOROUGH DEBRIDEMENT AND I&D WERE PERFORMED. THE HEAD AND DM POLY LINER THAT WERE REMOVED HAD BEEN PLACED ON (B)(3) 2023 DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM OCCURRED. DOI: (B)(3) 2023 (OTHER IMPLANTS). DOI: (B)(3) 2023 (THE HEAD AND DM POLY LINER). DOR: (B)(3) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18358904 ↗
• MalfunctionJun 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE HARD PLASTIC PACKAGING DAMAGED. INNER PACKAGE WAS INTACT, DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14834374 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED, WASHED OUT ONE MONTH PRIOR WITH NO SUCCESS. WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14601133 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT FOOT DROP. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2018; (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Nerve Damage

  MAUDE report 12309145 ↗
• InjuryDec 29, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL, HAD A GREATER TROCHANTER FRACTURE AND THE STEM BECAME LOOSE AT THE BONE TO IMPLANT INTERFACE. THEN, REVISED TO A LONGER STEM. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 11089022 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP REMOVED, PROSTALAC PLACED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10190343 ↗
• InjuryNov 29, 2018Unstable; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Unstable; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND DISLOCATION.

  Patient problems: No Code Available

  MAUDE report 8114787 ↗