Alteon 01-010-21-4245Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862282156), received between Dec 30, 2025 and Jan 12, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CONVERSION FROM AN IMFEMORAL NAIL TO A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, DURING PHYSICAL THERAPY AND WEIGHT-BEARING, THE PATIENT EXPERIENCED A MIDSHAFT FEMORAL FRACTURE. AS A RESULT, THE PATIENT UNDERWENT AN ATTEMPTED SURGERY THE DAY AFTER INITIAL IMPLANTATION WHICH HAD TO BE ABORTED DUE TO BLOOD LOSS. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THE REVISION WAS COMPLETED AT A LATER DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24035353 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CONVERSION FROM AN IM FEMORAL NAIL TO A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, DURING PHYSICAL THERAPY AND WEIGHT-BEARING, THE PATIENT EXPERIENCED A MIDSHAFT FEMORAL FRACTURE. AS A RESULT, THE PATIENT UNDERWENT A REVISION SURGERY AND FRACTURE FIXATION APPROXIMATELY 3 WEEKS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Periprosthetic fracture

  MAUDE report 23929463 ↗