Alteon 01-030-01-0552Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862549198), received between May 23, 2024 and May 23, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K182502); they may or may not involve this specific model.

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.

• InjuryMay 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 60 Y/O FEMALE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 2 YEARS 3 MONTHS POST OP. THE PATIENT HAD AN ORIGINAL EXACTECH THA. THE PATIENT PRESENTED TO DOCTORS OFFICE WITH COMPLAINTS OF THEIR LEFT HIP. THE PATIENT REPORTED PAIN, INSTABILITY, AND DISSATISFACTION. IT WAS NOTED AND SHOWN ON THE X-RAY THAT THE ACETABULAR CUP IS NOT IN AN IDEAL POSITION. THE PATIENT WAS SCHEDULED FOR LEFT HIP REVISION WITH ACETABULAR CUP REVISION. THE PATIENT UNDERWENT LEFT HIP REVISION. DURING THE REVISION, THE FEMORAL HEAD WAS REMOVED. THE ACETABULAR CUP AND LINER WERE REMOVED, THE HIP JOINT WAS DEBRIDED, AND PREPPED FOR A NEW ZB G7 CLUSTER-HOLE CUP. IT WAS IMPLANTED WITH SCREWS AND A LIPPED LINER. A NEW 36MM +10 MM HEAD WAS IMPLANTED ON THE FEMORAL STEM. THE PATIENT LEFT THE OR STABLE. PRODUCT NOT RETURNING: DISCARDED AT THE FACILITY

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Pain

  MAUDE report 19386740 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182502. One submission often covers many models, so check the product and lot details in each record.

• Z-1167-2025 · Dec 31, 2024 · Open, Classified
  Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G22
• Z-0578-2024 · Nov 21, 2023 · Open, Classified
  Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536