ACTIS 101011100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295380504), received between Jun 10, 2020 and Nov 5, 2025 — classified as 4 injuries, 1 malfunction.

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

• InjuryNov 5, 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 RIGHT HIP. EXTRACTION OF IMPLANTS WERE DONE. STAGE 1 ANTIBIOTIC SPACER PLACEMENT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23476625 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ACTIS PINNACLE IMPLANT SURGERY ON (B)(6) 2024. THE PATIENT PRESENTED AT HOSPITAL TEN DAYS LATER FOR PAIN. STEM WAS LOOSE WITH A FX. SURGEON FELT THE PATIENT LOOSENED THEN FRACTURED. THE SURGEON REMOVED STEM AND IMPLANTED A RECLAIM MONOBLOC. THE SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture; Pain

  MAUDE report 21071916 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED IMPLANT, ALL IMPLANTS REMOVED. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19478403 ↗
• InjurySep 8, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT REPORTED THIGH PAIN 6 MONTHS AGO. STEM WAS DETERMINED TO BE LOOSE AT BONE TO IMPLANT INTERFACE AND WAS REVISED. DOI: (B)(6) 2020, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17713178 ↗
• MalfunctionJun 10, 2020Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN THE SALES REP WAS GETTING READY FOR A HIP SURGERY AND STARTED TO PULL IMPLANTS TO LOAD ON HIS CART, HE NOTICED A FUNNY SOUND IN ONE OF THE ACTIS BOXES. AS HE SHOOK THE BOX, IT SOUNDED LIKE A FEW PIECES OF PLASTIC WERE RUMBLING AROUND. WHEN HE OPENED THE BOX THE STERILE PACKAGING SEEM TO BE CRACKED & A FEW PIECES OF PLASTIC FELL OUT. THE IMPLANT WAS NOT SUITABLE FOR SURGERY. HE THEN REQUESTED A REPLACEMENT AND SENT THIS ONE BACK TO THEIR HOME OFFICE. DOE: (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137684 ↗