R3 71935851Recalls & reported problems
Smith & Nephew, Inc. · R3 20 DEG XLPE ACET LNR 36MM ID X 50MM OD · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556776155), received between Apr 24, 2025 and Oct 8, 2025 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Joint Dislocation1
- Purulent Discharge1
- Wound Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR PROCEDURE, THAT HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTION THAT WAS CONFIRMED BY LAB TESTS AND THE WOUND WAS FULL OF PUS AND LEAKING. THIS ADVERSE EVENT WAS TREATED BY A WASHOUT AND A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 50MM AND ONE (1) OXINIUM FEM HD 12/14 36 MM -3 WERE EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Purulent Discharge; Wound Infection
MAUDE report 23245421 ↗InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2024, PATIENT HAD A DISLOCATED HIP SINCE NOVEMBER. WHEN TRYING TO RELOCATE THE HIP IT WOULD DISLOCATE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025 IN WHICH A R3 20 DEG XLPE ACET LNR 36MM X 50MM AND A COCR 12/14 FEM HEAD 36MM -3 WERE EXPLANTED AND REPLACED WITH AN ANTEVERTED LINER. STABILITY WAS ESTABLISHED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 21906165 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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