NA 1115-27-000Recalls & reported problems
Depuy Orthopaedics, Inc. · ACS ENDURON POLYETHYLENE ACETABULAR LINER 20 DEGREE 28mm ID GROUP 2 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295004868), received between Feb 22, 2019 and Oct 1, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Naturally Worn” (2 reports).
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
Device problems
- Naturally Worn2
- Fracture1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2019Fracture; Naturally Worn; Fracture; Naturally Worn
PPF AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THAT THE PATIENT WAS REVISED TO ADDRESS SEVERE ACETABULAR LINER WEAR WITH FRACTURE OF THE LINER. DOI: (B)(6) 1990. DOR: (B)(6) 2005, (LEFT HIP INITIAL). BILATERAL: (B)(4), (RIGHT HIP). PLEASE SEE: (B)(4), (LEFT HIP REVISION).
Patient problems: No Code Available
MAUDE report 9139930 ↗MalfunctionFeb 22, 2019Naturally Worn; Naturally Worn
SURGEON IS ORDERING A PATIENT SPECIFIC PE-HIP INLAY LEFT SIDE BECAUSE OF NORMAL PE WEAR AFTER 26.5 YEARS. DOI: (B)(6) 1992, DOR: PLANNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8362706 ↗
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
- 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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