R3 71332412Recalls & reported problems
Smith & Nephew, Inc. · R3 ANTEVERTED XLPE LINER 40MM INNER DIAMETER X OUTER DIAMETER 56MM +4 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556308493), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
1 other recall cover devices cleared under the same FDA submission (K182535, K211176); 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
Most reported problems
Device problems
- Fracture1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Fracture; Fracture
IT WAS REPORTED THAT, AFTER A THR SURGERY IN WHICH AN R3 ANTE XLPE LNR 40MM X 56MM LINER AND A 40MM FEMORAL HEAD WERE IMPLANTED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS THAT RESULTED IN AN ER VISIT. THIS ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2025, DURING WHICH IT WAS OBSERVED THAT THE LIP OF THE R3 ANTE XLPE LNR 40MM X 56MM LINER WAS BROKEN OFF. THE BROKEN FRAGMENT WAS RETRIEVED. THE LINER AND HEAD WERE REPLACED WITH AN OR30 IMPLANT, AND STABILITY WAS ACHIEVED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 23634893 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K182535, K211176. One submission often covers many models, so check the product and lot details in each record.
- Z-0326-2025 · Oct 15, 2024 · Open, ClassifiedTandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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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