Alteon 01-010-16-4245Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862282101), received between Apr 21, 2021 and Apr 21, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2021Migration; Migration

  AS REPORTED, APPROXIMATELY 3 MONTHS POSTOP THE INITIAL R THA THIS FEMALE PATIENT WAS BROUGHT TO SURGERY FOR A SUBSIDED 16X245 MONOBLOC STEM. THE R HIP WAS DISLOCATED, THE FEMORAL HEAD AND THE STEM WERE REMOVED, THE ACETABULAR COMPONENT WAS EXPOSED, AND THE POLY LINER WAS REMOVED. THE PATIENT RECEIVED A NEW G1 XLE EXTENDED COVERAGE LINER, THE FEMUR WAS REAMED UP TO A 19X245 STEM AND A NEW 19X245 STEM WAS IMPLANTED. THE NEW 32 +7 BIOLOX HEAD WAS IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE IMPLANTS WERE DISCARDED BY HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 11702069 ↗