Alteon 01-030-42-0536Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862549945), received between Apr 26, 2021 and Sep 2, 2025 — classified as 2 injuries.

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

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Dec 31, 2024Class IIOpen, Classified

   Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

   Z-1167-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0578-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

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.

• InjurySep 2, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 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. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISCARDED AT THE FACILITY

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

  MAUDE report 22938642 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4 WEEKS POSTOP THE INITIAL R THA, THE FEMALE PATIENT HAD SYMPTOMS OF POSSIBLE INFECTION R HIP. SHE WAS BROUGHT BACK FOR AN IRRIGATION DEBRIDEMENT WITH A HEAD AND POLY SWAP. THIS HIP WAS DISLOCATED, THE FEMORAL HEAD WAS REMOVED, THE ACETABULAR COMPONENT EXPOSED, THE POLY LINER REMOVED. AFTER IRRIGATION, A NEW POLY LINER AND HEAD WAS RE 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: Bacterial Infection

  MAUDE report 11729430 ↗