R3 ACETABULARRecalls & reported problems across all models
Smith & Nephew, Inc. · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 224
- Deaths reported
- 2
- Injuries reported
- 208
- Recalls
- 0
We found 24 models of R3 ACETABULAR by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 224 adverse event reports in the FDA's MAUDE database, received between Apr 12, 2017 and Apr 20, 2026 — classified as 2 deaths, 208 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (42 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported R3 ACETABULAR problems
Device problems
- Adverse Event Without Identified Device or Use Problem82
- Insufficient Device Problem Information42
- Fracture12
- Biocompatibility11
- Break10
- Device Dislodged or Dislocated9
- Connection Problem7
- Failure to Osseointegrate5
Patient problems
- Injury59
- Pain40
- Unspecified Infection23
- Joint Dislocation21
- Metal Related Pathology21
- Failure of Implant19
- No Clinical Signs, Symptoms or Conditions19
- Bone Fracture(s)7
R3 ACETABULAR models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- R3 ACETABULAR 71335552Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 death30 reports
- R3 ACETABULAR 71335556Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented27 reports
- R3 ACETABULAR 71335550Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented26 reports
- R3 ACETABULAR 71335554Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented23 reports
- R3 ACETABULAR 71335548Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 death16 reports
- R3 ACETABULAR 71335558Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented16 reports
- R3 ACETABULAR 71335560Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented12 reports
- R3 ACETABULAR 71338954Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented9 reports
- R3 ACETABULAR 71331856Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented9 reports
- R3 ACETABULAR 71331852Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented8 reports
- R3 ACETABULAR 71338952Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented7 reports
- R3 ACETABULAR 71331850Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented7 reports
- R3 ACETABULAR 71331948Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous6 reports
- R3 ACETABULAR 71331854Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented5 reports
- R3 ACETABULAR 71331858Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented5 reports
- R3 ACETABULAR 71335562Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented4 reports
- R3 ACETABULAR 71338950Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- R3 ACETABULAR 71338956Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented3 reports
- R3 ACETABULAR 71338948Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- R3 ACETABULAR 71335564Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented2 reports
- R3 ACETABULAR 71338958Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- R3 ACETABULAR 71331848Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- R3 ACETABULAR 71331860Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented1 report
- R3 ACETABULAR 71335568Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
Recent R3 ACETABULAR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THA PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED INSTABILITY OF THE JOINT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH A SYN POR HO FEM COM SZ 13, AN R3 3 HOLE ACET SHELL 50MM, AN REF SPHER HEAD SCREW 25MM, AN OR3O DUAL MOBILITY LINER 38/50, AN OR3O DUAL MOBILITY XLPE INSERT 28/38 AND AN OXINIUM FEM HD 12/14 28MM +0 WERE REPLACED. THE PATIENT LEFT SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Joint Laxity
MAUDE report 24924219 ↗InjuryMar 30, 2026Biocompatibility
IT WAS REPORTED THAT, AFTER A BILATERAL THA SURGERY PERFORMED ON (B)(6) 2012, THE PLAINTIFF HAD CLINICAL FINDINGS CONSISTENT WITH METALOSIS/TRUNIONOSIS DUE TO MODULAR COMPONENT. A RIGHT REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2026. IT IS UNKNOWN WHICH IMPLANTS WERE REMOVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Metal Related Pathology
MAUDE report 24736623 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT WAS DEEMED TO BE "INFECTED" PER THE SURGEON. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) SYN POR FEM COMP SZ 14, ONE (1) R3 3 HOLE ACET SHELL 52MM, ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 52MM, ONE (1) OXINIUM FEM HD 12/14 36 MM +0 AND ONE (1) REF SPHER HEAD SCREW 25MM WERE REMOVED. THE PATIENT LEFT SURGERY IN GOOD HEALTH.
Patient problems: Unspecified Infection
MAUDE report 24114870 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A REVISION SURGERY PERFORMED ON (B)(6) 2019 DUE TO STEM SUSPECTED LOOSENING, THE PATIENT HAS EXPERIENCED PAIN PROBLEMS WHEN WALKING, SITTING, LAYING DOWN WHILE HAVING IMPLANTED THE R3 ACETABULAR SHELL. IT IS UNKNOWN HOW THE ISSUE IS BEING HANDLED.
Patient problems: Pain
MAUDE report 23302996 ↗InjuryOct 12, 2025Degraded; Biocompatibility; Degraded; Biocompatibility
IT WAS REPORTED THAT, AFTER THE PATIENT UNDERWENT A RIGHT R3 THR WITH ANTHOLOGY ON (B)(6) 2017 DUE TO AN ADVANCED AVASCULAR NECROSIS WITH EARLY COLLAPSE, IN 2025 RADIOGRAPHIC FINDINGS DISCOVERED THAT THERE WAS SIGNIFICANT RIGHT HIP JOINT DESTRUCTION. COBALT AND CHROMIUM WERE NORMAL. THE PATIENT WAS ALSO EXPERIENCING DISABLING PAIN AND FUNCTIONAL DISABILITY; SYMPTOMS WERE WORSE WITH AMBULATION AND ACTIVITIES. A PSEUDOTUMOR WAS FOUND ON THE RIGHT HIP. SCAN SHOWED SIGNIFICANT ANTEVERSION OF HIP CUP WITH NOTCHING WEAR IN THE FEMORAL NECK ON THE ACETABULAR CUP. CONSERVATIVE TREATMENT WITH NSAIDS AND ACTIVITY MODIFICATION HAD BEEN USED WITH NO RESULT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 AND METALLOSIS WAS NOTICED. A GRAY PURULENT GELATINOUS FLUID CAME OUT OF THE HIP JOINT AND WAS ASPIRATED AND SENT FOR CULTURE AND COBALT AND CHROMIUM QUANTITATIVE ANALYSIS. THE MASS FOUND WAS FILLED MOSTLY WITH THE SAME GRAY SLUDGE FOUND IN THE HIP CAPSULE. INSPECTION OF THE HIP FOUND THAT THERE WAS SIGNIFICANT WEAR OF THE POSTERIOR INFERIOR ASPECT OF THE CUP AND POLY LINER. THE CUP WAS SIGNIFICANTLY ANTEVERTED COMPARED TO HIS ANATOMIC ACETABULAR POSITION. THERE WAS 1-2MM OF WEAR INTO THE POST
Patient problems: Metal Related Pathology; Pain
MAUDE report 23275071 ↗MalfunctionSep 25, 2025Positioning Problem; Positioning Problem
IT WAS REPORTED THAT DURING A THR SURGERY, THE LINER AND CUP WERE FOUND TO BE INCOMPATIBLE. AFTER A DELAY OF MORE THAN 30 MINUTES, THE PROCEDURE WAS RESUMED USING A SIMILAR SMITH & NEPHEW DEVICE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23143958 ↗InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING ACETABULAR CUP AND PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 3 HOLE ACET SHELL MM48, ONE (1) R3 0 DEG +4 XLPE ACET LNR 32MM X 48MM AND ONE (1) OXINIUM FEM HD 12/14 32MM +0 WERE EXPLANTED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.
Patient problems: Aseptic loosening; Pain
MAUDE report 22685083 ↗InjuryJul 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2023, PATIENT EXPERIENCED THAT WHEN BENDING OVER, THE HIP LOCKS AND IT TAKES A WHILE TO GET IT UNLOCKED. PATIENT EXPRESSED THIS IS VERY PAINFUL UNTIL IT UNLOCKS. IN ADDITION, SURGEON AND HIS COLLEAGUE THINK MAYBE A NEW CUP OR CUT THE TENDON MAY BE REQUIRED. PATIENT EXPRESSED THAT SHE CANNOT GARDENING AND IS CAREFUL WHEN DOING THINGS IN THE HOUSE. IT IS UNKNOWN HOW THIS ADVERSE EVENT HAS BEEN ADDRESSED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Joint locking; Pain
MAUDE report 22491265 ↗InjuryJun 13, 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) 2021, THE PATIENT EXPERIENCED A PERIPROSTHETIC INFECTION; THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, DURING WHICH ONE BIOLOX DELTA CE BALL HEAD 12/14 36L, ONE R3 36MM ID INTL DLT CER LNR 56MM, ONE R3 3 HOLE ACET SHELL 56MM, AND ONE POLARSTEM STEM STD TI/HA 4 NON-CEM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 22203956 ↗InjuryApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING ACETABULAR CUP. THIS ADVERSE EVENT WAS SOLVED/TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 0 DEG +4 XLPE ACET LNR 32MM X 48MM, ONE (1) OXINIUM FEM HD 12/14 32MM +0 AND ONE (1) R3 3 HOLE ACET SHELL MM48 WERE EXPLANTED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 21934234 ↗InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6)2024, IN WHICH ONE (1) R3 3 HOLE ACET SHELL 52MM, ONE (1) ANTHOLOGY SO POR PL HA SZ 1, ONE (1) OXINIUM FEM HD 12/14 32MM -3, ONE (1) R3 0 DEG XLPE ACET LNR 32MM X 52MM, AND TWO (2) REF SPHER HEAD SCREW 20MM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Medical device site infection
MAUDE report 21191251 ↗InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2023, PATIENT EXPERIENCED ASEPTIC LOOSENING CUP. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, THE R3 3 HOLE ACET SHELL 50MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Aseptic loosening
MAUDE report 21068808 ↗InjuryDec 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE R3 3 HOLE ACET SHELL 52MM WAS NOTICED TO BE MISPOSITIONED AND AT RISK OF DISLOCATING. X-RAYS POST-OP SHOWED THE CUP TO BE TOO OPEN AND THE HEAD STARTING TO MIGRATE SUPERIORLY A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH THE CUP SIZE WAS REAMED UP FROM A 52MM TO A 54MM. THE PATIENT'S HIP IS NOW STABLE.
Patient problems: Failure of Implant
MAUDE report 20851177 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A RIGHT THA, WAS PERFORMED ON (B)(6) 2011, THE PATIENT STARTED DEVELOPING RIGHT GROIN PAIN ON OR ABOUT (B)(6) 2024. TEST IMAGING ON (B)(6) 2024 SHOWED A STABLE RIGHT THA WITHOUT EVIDENCE OF PERIPROSTHETIC FRACTURE, LUCENCY, OR EVIDENCE OF SUBSIDENCE. BUT A QUESTIONABLE IRREGULARITY OF THE RIGHT INFERIOR PUBIC RAMUS, WHICH COULD REFLECT A NONDISPLACED FRACTURE VERSUS ARTIFACT WAS OBSERVED. THEY LATER EXPERIENCED A SPONTANEOUS PELVIC FRACTURE WITHOUT TRAUMA, ON OR ABOUT (B)(6) 2024. IT WAS MENTIONED THAT IT IS MORE LIKELY THAN NOT THAT PRIOR HIP SURGERIES AND ALTERED ANATOMY ARE A FACTOR IN THE STRESS RESPONSE CAUSING THIS FRACTURE. LATERALITY WAS NOT SPECIFIED. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: Arthralgia; Bone Fracture(s); Hip Fracture
MAUDE report 20843197 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2024, PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE R3 3 HOLE ACET SHELL 62MM, THE R3 20 DEG XLPE ACET LNR 36MM X 62MM, THE BIOLOX DELTA CE BALL HEAD 12/14 36S AND THE POLARSTEM STEM STD TI/HA 8 NON CEM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS FINE.
Patient problems: Drug Resistant Bacterial Infection; Medical device site infection
MAUDE report 20802998 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page