Alteon 01-030-40-0436Recalls & reported problems
Exactech, Inc. · Alteon Cup · Class 2 · Implant
All models of Alteon (135)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862549563), received between Apr 21, 2026 and Apr 21, 2026 — classified as 1 injury.
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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Joint Dislocation1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Unstable; Device Dislodged or Dislocated
AS REPORTED, APPROXIMATELY 3 YEARS AND 1 MONTH POST THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY, AND FOLLOWING MULTIPLE DISLOCATIONS AND PAIN, THE PATIENT WAS REVISED DUE TO INSTABILITY AND THE RECALLED LINER WAS REMOVED. STABILITY OF THE ACETABULAR COMPONENT WAS CHECKED AND FOUND TO BE ADEQUATE AND STABLE. A HIP ASPIRATION DEMONSTRATED NO GROWTH ON CULTURE AND WAS NOT INDICATIVE OF INFECTION. THE PATIENT WAS DISCHARGED HOME WITH HOME HEALTH.
Patient problems: Joint Dislocation; Joint Laxity; Pain
MAUDE report 24948330 ↗
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, ClassifiedExactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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