REVISION REVISION HIP - Ti6Al4V (REF 3814.15.010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390003889), received between Jul 11, 2017 and Jun 23, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO LOOSENING OF THE FEMORAL REVISION MOD. STEM Ø18MM (PRODUCT CODE: 3814.15.010, LOT: 1707533 - STER: 2200224). DURING REVISION THE STEM WITH REVISION LATER. NECK H.60MM (PRODUCT CODE: 7515.15.110, LOT: 2202563 - STER: 2200085) WERE EXPLANTED. CEMENTED STEM WAS IMPLANTED. PATIENT: FEMALE, 82 YEARS OLD. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023. EVENT OCCURRED IN ITALY.

  Patient problems: Insufficient Information

  MAUDE report 25589717 ↗
• InjuryDec 2, 2025Break; Break

  REVISION SURGERY DUE TO FRACTURE OF THE CONE ATTACHMENT AT THE PROXIMAL SHAFT END OF THE MODULAR PROSTHESIS. EMERGENCY DEPARTMENT PRESENTATION TO THE EMERGENCY ROOM DUE TO PAIN IN THE LEFT HIP AFTER A FALL. ACCORDING TO THE AVAILABEL INFORMATION, THE PATIENT TWISTED HIS LEFT HIP JOINT AND, AS A RESULT, FELT HIS LEG GIVE WAY AND FELL BACKWARDS. SINCE THEN, HE HAS HAD AN IMMOBILIZING PAIN IN HIS LEFT HIP JOINT. IN ADDITION ACETABULAR FLOOR FRACTURE AND LOOSENING AROUND THE ACETABULAR PROSTHESIS AND PERIPROSTHETIC OSTEOLYSIS WITH PERIPROSTHETIC FRACTURE OF THE PROXIMAL FEMUR ON THE LEFT SIDE WERE REPORTED. PREVIOUS SURGERY TOOK PLACE IN 2007. THIS EVENT OCCURRED IN GERMANY.

  Patient problems: Implant Pain

  MAUDE report 23692502 ↗
• InjuryJul 11, 2017Patient Device Interaction Problem; Fracture; Patient Device Interaction Problem

  FIRST HIP REVISION SURGERY - DONE ABOUT 4 YEARS AGO - DUE TO BONE FRACTURE. AT THAT TIME, COMPETITOR'S PRODUCTS ORIGINALLY IMPLANTED (UNKNOWN PRIMARY IMPLANT DATE) WERE REMOVED AND A REVISION STEM WAS IMPLANTED. DURING A SECOND HIP REVISION SURGERY, PERFORMED ON (B)(6) OF 2017 DUE TO INFECTION, SURGEON COULD NOT SEPARATE THE NECK FROM THE STEM. ACCORDING TO THE INFO REPORTED, NECK + STEM WERE REMOVED TOGETHER ONLY BY PERFORMING AN EXTENDED TROCHANTERIC OSTEOTOMY. SURGERY COMPLETED BY INSERTING CEMENT SPACER CONTAINING ANTIBIOTIC. EVENT HAPPENED IN (B)(6).

  Patient problems: Medical device site infection; No Code Available; Unspecified Infection

  MAUDE report 6700080 ↗