NA 1115-28-025Recalls & reported problems
Depuy Orthopaedics, Inc. · ACS ENDURON POLYETHYLENE ACETABULAR LINER 20 DEGREE 28mm ID GROUP 3 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295004899), received between Mar 14, 2019 and Jul 22, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Device-Device Incompatibility1
- Difficult to Insert1
- Naturally Worn1
- Off-Label Use1
Patient problems
- Insufficient Information1
- Joint Dislocation1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE DOCTOR SAID PATIENT HAD HIP DONE OVER 35 YEARS AGO. THE CUP WAS IDENTIFIED AS A DEPUY ACS CUP, TO WHICH SURGEON PERFORMED POLY EXCHANGE. THE OLD POLY HAD SEVERE WEAR, SO A NEW 20 DEGREE 28MM ID GROUP 3 LINER WAS IMPLANTED. THE HEAD THAT WAS REMOVED WAS CONFIRMED TO BE A LARGE TAPER, BUT ALL NUMBERS INDICATING NECK LENGTH HAD BEEN WORN AWAY AND WAS UNABLE TO BE READ. TRIAL REDUCTIONS WERE PERFORMED WITH 28MM LARGE TAPER TRIALS AND THE +8 WAS THE PREFERRED OPTION. THE REAL HEAD WAS THEN OPENED AND IMPLANTED. STABILITY OF THE HIP WAS THEN CONFIRMED AND THE CLOSING PROCESS BEGAN. NO ADVERSE EVENTS OR DELAYS TOOK PLACE. DOI: 35 YEARS AGO. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SIDE.
Patient problems: Insufficient Information
MAUDE report 22569348 ↗MalfunctionJun 3, 2020Difficult to Insert; Off-Label Use; Device-Device Incompatibility; Difficult to Insert; Off-Label Use; Device-Device Incompatibility
THE PATIENT UNDERGO REVISION SURGERY DUE TO POLY WEAR THAT WAS REPORTED IN (B)(4). THE LINER WOULD NOT LOCK INTO THE CUP. A SECOND LINER WAS THEN OPENED WITH THE SAME RESULT. THE DOCTOR DETERMINED THAT THE LOCKING MECHANISM HAD BEEN COMPROMISED SO HE ELECTED TO CEMENT A LINER IN PLACE. DOE: (B)(6) 2020 RIGHT SIDE.
Patient problems: Not Applicable
MAUDE report 10116939 ↗InjuryMar 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
SUBJECT ID: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO DISLOCATION. DOI CUP: (B)(6) 1996; DOI HEAD AND LINER: (B)(6) 2017; DOR: (B)(6) 2019; (LEFT HIP). HEAD, LINER AND CUP REVISED.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 8421211 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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