R3, STIKTITERecalls & reported problems across all models

We found 10 models of R3, STIKTITE by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2017 and May 3, 2026 — classified as 33 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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

Most reported R3, STIKTITE problems

R3, STIKTITE models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• R3, STIKTITE 71338666

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  8 reports
• R3, STIKTITE 71338665

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  7 reports
• R3 STIKTITE 71335546

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  7 reports
• R3, STIKTITE 71338664

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  5 reports
• R3, STIKTITE 71338663

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  5 reports
• R3, STIKTITE 71338668

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  3 reports
• R3, STIKTITE 71338667

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  2 reports
• R3 STIKTITE 71331846

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  2 reports
• R3, STIKTITE 71338669

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  1 report
• R3, STIKTITE 71338673

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
  1 report

Recent R3, STIKTITE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A DISLOCATION OF A HIP REPLACEMENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A R3 MULTI HOLE ACETABULAR SHELL 48MM WAS EXCHANGED TO A DUAL MOBILITY CONSTRUCT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25064273 ↗
• MalfunctionNov 5, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A THR, AFTER IMPLANTING A R3 0 HOLE ACET SHELL 46MM, IT MOVED OUT OF POSITIONING CAUSING IT TO BE DISCARDED AND REPLACED FOR A 3 HOLE CUP. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: Perforation

  MAUDE report 20610383 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT HIP REVISION SURGERY PERFORMED ON (B)(6) 2018 TO REMOVE AN ANTIBIOTIC SPACER WITH CONVERSION TO THA DEFINITIVE IMPLANTS, THE PATIENT SUSTAINED A RECURRENT PERIPROSTHETIC JOINT INFECTION THAT REQUIRED A RE-REVISION OF THE JOINT PROSTHESIS ON (B)(6) 2018. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20375952 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA ON (B)(6) 2021, PATIENT REQUIRED READMISSION FOR AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2021 DUE TO INFECTION AND INFLAMMATORY REACTION OF INTERNAL RIGHT HIP PROSTHESIS. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19554518 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A DISLOCATION. AN ANTEVERSION OF THE R3 CUP WAS NOTED TO BE A LITTLE INSUFFICIENT. A REVISION SURGERY WAS PERFOMRED ON (B)(6) 2023, IN WHICH THE CUP, LINER AND SCREW WERE EXCHANGED TO COMPETITOR PRODUCTS (ZIMMER). ALSO, THE FEMORAL HEAD WAS EXCHANGED TO OXINIUM HEAD, JUST THE STEM WAS NOT EXPLANTED. HOWEVER, THE SURGEON DID NOT THINK IT WAS A FAILURE OF THE DEVICES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 18120750 ↗
• InjuryMar 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2023, IN WHICH ONE (1) ANTHOLOGY HO POROUS SZ 8, ONE (1) OXINIUM FEM HD 12/14 32MM +8, ONE (1) R3 20 DEG XLPE ACET LNR 32MM X 52MM AND ONE (1) R3 MULTI HOLE ACETABULAR SHELL 52MM WERE EXPLANTED. PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16569580 ↗
• InjuryApr 25, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A THR ON AN UNKNOWN DATE, PATIENT EXPERIENCED INCREASED HIP PAIN AND SWELLING. X-RAYS SHOW FRACTURE AND TESTS PERFORMED REVEAL POTENTIAL INFECTION,. A REVISION WAS PERFORMED ON (B)(6) 2022, TREATMENT NOT DECIDED YET. OUTCOME: RESOLVING. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 14192054 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2021. THE PATIENT EXPERIENCED RECURRENT ANTERIOR DISLOCATION OF THE RIGHT HIPS; THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REVISE THE R3 MULTI HOLE ACETABULAR SHELL 54MM, OR3O DUAL MOBILITY LINER 42/54 AND THE OR3O DM XLPE INSERT 28/42. SURGICAL OUTCOME WAS SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13282073 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT HIP REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2015 DUE TO FAILED METAL-ON-METAL PROSTHESIS, PAIN AND ELEVATED METAL ION LEVELS, THE PATIENT EXPERIENCED AN HEMATOMA WHICH REQUIRED AN INCISION AND DRAINAGE PROCEDURE ON (B)(6) 2015. SEVERAL CLOTS AND SOME MINOR BLEEDING IN THE RIGHT HIP WERE REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM.

  Patient problems: Hematoma

  MAUDE report 12813235 ↗
• InjuryOct 15, 2021Biocompatibility; Biocompatibility

  US LEGAL MDL: IT WAS REPORTED THAT AFTER A LEFT R3-THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2018, PLAINTIFF EXPERIENCED OSTEOLYSIS WITH LOOSENING ACETABULAR COMPONENT, PSEUDOTUMOR AND ELEVATED COBALT AND CHROMIUM LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY LARGE AMOUNT OF CLOUDY STRAW-COLORED JOINT FLUID EMANATED FROM THE INCISION, THE TRUNNION WAS INSPECTED AND NOTED TO DEMONSTRATE BLACK METALLOSIS AND OSTEOLYSIS NEAR THE ACETABULAR COMPONENT AND FEMORAL COMPONENT WAS NOTICED. THE CUP, HEAD, LINER, AND SLEEVE WERE EXPLANTED AND REPLACE. THE STEM WAS WELL FIXED, SO IT WAS CONSERVED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 12639099 ↗
• InjurySep 17, 2021Adverse 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) 2015, THE PATIENT EXPERIENCED INFECTION AND DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 12492121 ↗
• MalfunctionJul 6, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE R3 20 DEG XLPE ACET LNR 28MM X 46MM COME OUT AFTER TRYING SEVERAL TIMES IN THE R3 3 HOLE ACET SHELL MM46. FINALLY, ANOTHER LINER AND CUP WERE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125594 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ''US LEGAL MDL'': IT WAS REPORTED THAT, AFTER 3 MOTHS OF A REVISION SURGERY PERFORMED ON (B)(6) 2016 (COVERED UNDER (B)(4)), THE PATIENT EXPERIENCED PAIN. CLINICAL EXAMS REVEALED RIGHT HIP HETEROTOPIC OSSIFICATION. HIP ASPIRATION TEST WAS PERFORMED AND CAME NEGATIVE FOR INFECTION. THE EVENT WAS TREATED WITH INJECTIONS, ANTI-INFLAMMATORY TREATMENT, AND PHYSICAL THERAPY. THE PATIENT OUTCOME IS STABLE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 11940872 ↗
• InjuryJan 29, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED TWO DISLOCATIONS THAT REQUIERED RELOCATION OF THE JOINT. FOR THE THIRD DISLOCATION THEREFORE PATIENT HAD TO BE TAKEN TO THE OR. A REVISION SURGERY WAS PERFORMED TO TREAT THIS EVENT. THE SYNERGY STEM WAS WELL FIXED, BUT THE SURGEON FELT LIKE THE R3 MULTI HOLE ACETABULAR SHELL 54MM WAS MALPOSITIONED; THEREFORE, IT WAS REMOVED. THE R3 20 DEG XLPE ACET LNR 36MM X 58MM AND COCR 12/14 FEM HEAD 36MM +0 WERE ALSO REMOVED. THE SURGEON REPOSITIONED THE CUP AND IMPLANTED A REDAPT MODULAR CUP WITH OR30 ASSEMBLY, ACETABULAR SCREWS AND 28MM OXINIUM HEAD. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Joint Dislocation

  MAUDE report 11250218 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A LOOSE, INFECTED FEMORAL COMPONENT. DURING THIS PROCEDURE THE IMPLANTED LINER WAS REMOVED AND A ANTIBIOTIC SPACER WAS PUT IN PLACE. THE PATIENT THEN UNDERWENT REVISION SURGERY, 5 OR 6 WEEKS LATER, DUE TO TIMEFRAME OF 2-STAGE REVISION. THE WHOLE S&N SET WAS REMOVED AND REPLACED.

  Patient problems: Impaired Healing; Joint Laxity; Osteolysis; Subluxation; Unspecified Infection

  MAUDE report 10884170 ↗

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