Alteon 01-030-42-0740Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862550057), received between Jan 28, 2022 and May 23, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

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 ↗

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.

• InjuryMay 23, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 5 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING FROM PREMATURE REVISION SURGERY, DISLOCATIONS AND MULTIPLE FALLS, LOSS OF MOBILITY AND ENJOYMENT OF LIFE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19386686 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A (B)(6) PATIENT HAD RIGHT THA REVISION OF THE STEM, HEAD, AND LINER FOR AN UNKNOWN REASON. ALTEON CUP STAYED AND A NEW EXACTECH EXTENDED COVERAGE LINER +40MM HEAD WAS IMPLANTED. THE STEM AND HEAD WERE REVISED TO A DIFFERENT COMPANY. NO OTHER IMPLANT INFORMATION IS KNOWN. THERE WAS NO BREAKAGE OF DEVICES. THERE WAS 30-45 MINUTE SURGICAL DELAY/ PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE RECEIVE; HOWEVER, THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS IMPLANTS THAT WERE REMOVED WERE THROWN AWAY BY THE STAFF AT THE FACILITY.

  Patient problems: Failure of Implant

  MAUDE report 13389500 ↗

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-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