OXINIUMRecalls & reported problems across all models
Smith & Nephew, Inc. · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 570
- Deaths reported
- 0
- Injuries reported
- 542
- Recalls
- 0
We found 36 models of OXINIUM by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 570 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2017 and Jun 20, 2026 — classified as 542 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (101 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 OXINIUM problems
Device problems
- Adverse Event Without Identified Device or Use Problem269
- Device Dislodged or Dislocated101
- Insufficient Device Problem Information94
- Fracture14
- Unstable11
- Break10
- Unintended Movement9
- Scratched Material8
Patient problems
- Joint Dislocation173
- Injury132
- Unspecified Infection105
- Failure of Implant47
- Pain42
- No Clinical Signs, Symptoms or Conditions27
- Medical device site infection19
- Bone Fracture(s)17
OXINIUM models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OXINIUM 71343600Prosthesis, hip, semi-constrained, metal/polymer, cemented81 reports
- OXINIUM 71343200Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented58 reports
- OXINIUM 71343604Prosthesis, hip, semi-constrained, metal/polymer, cemented53 reports
- OXINIUM 71343603Prosthesis, hip, semi-constrained, metal/polymer, cemented41 reports
- OXINIUM 71343204Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented38 reports
- OXINIUM 71342800Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented35 reports
- OXINIUM 71343608Prosthesis, hip, semi-constrained, metal/polymer, cemented33 reports
- OXINIUM 71342340Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- OXINIUM 71342804Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented29 reports
- OXINIUM 71343203Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented28 reports
- OXINIUM 71343208Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented22 reports
- OXINIUM 71342808Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented15 reports
- OXINIUM 71342803Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented13 reports
- OXINIUM 71342200Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented13 reports
- OXINIUM 71342204Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented13 reports
- OXINIUM 71343612Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented12 reports
- OXINIUM 71342604Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10 reports
- OXINIUM 71342208Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- OXINIUM 71342600Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- OXINIUM 71341940Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- OXINIUM 71342608Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- OXINIUM 71341916Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- OXINIUM 71342812Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- OXINIUM 71341910Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- OXINIUM 71341909Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- OXINIUM 71342344Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- OXINIUM 71341941Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OXINIUM 71341939Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OXINIUM 71342816Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OXINIUM 71245034PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OXINIUM 71342288Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- OXINIUM 71342364Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- OXINIUM 71342368Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- OXINIUM 71343212Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OXINIUM 71343216Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- OXINIUM 71342212Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent OXINIUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT, DURING A HIP REPLACEMENT SURGERY, ONE (1) POLARSTEM DETACHABLE RASP 1, ONE (1) POLARSTEM DETACHABLE RASP 2, ONE (1) POLARSTEM TRIAL NECK STANDARD AND ONE (1) OXINIUM FEM HD (B)(6) 32MM +0 WERE HAVING FITTING ISSUES. THE PROCEDURE WAS RESUMED, AFTER 30 MINUTES OR LESS, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25570318 ↗MalfunctionJun 5, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT, BEFORE A THA SURGERY AND AFTER OPENING THE OUTER BOX, IT WAS NOTICED THAT THE INNER SEAL OF ONE (1) OXINIUM FEM HD 12/14 28MM +0 HAD A HOLE IN IT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25418065 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN ISSUE WITH THE LENGTH OF HER LEG, THIS WAS CHECKED WITH SOME POST OP X RAYS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) OXINIUM FEM HD 12/14 32MM +8 WAS REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unequal Limb Length
MAUDE report 25145360 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS AND THAT THE LENGTH OF THE HIP REPLACEMENT WAS SHORTER THAN THE NON-OPERATIVE SIDE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) OXINIUM FEM HD 12/14 36 MM +0 AND ONE (1) R3 0 DEG XLPE ACET LNR 36MM X 58MM WERE REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation; Unequal Limb Length
MAUDE report 25136383 ↗InjuryApr 15, 2026Material Deformation
IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE 40MM OXINIUM MODULAR HEAD (B)(4) AND THE R3 0 DEGREE XLPE ACET LNR 40MM ID X 60OD (B)(4) WERE SIGNIFICANTLY DAMAGED DUE TO THE CERAMIC PARTICLES THAT WERE STILL IN JOINT FROM A PREVIOUS CERAMIC LINER FRACTURE (UNKNOWN IF FROM S+N). THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE DEVICES WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24891030 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A THA THAT TOOK PLACE ON 2007, A REVISION SURGERY TOOK PLACE ON (B)(6) 2026 DUE TO THE DISLOCATION OF THE IMPLANT. THE RF INTERFIT ACET TH SZ 56, REF XLPE 32 20 DEG 54-56 F AND OXINIUM FEM HD 12/14 32MM +4 WERE EXCHANGED. NO MORE DETAILS AVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 24544050 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE OXINIUM FEM HD 12/14 28MM +0, THE OR3O DUAL MOBILITY LINER 42/54 AND THE OR3O DM XLPE INSERT 28/42 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 24480016 ↗MalfunctionFeb 24, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING A THR, WHEN OPENING THE PACKAGE OF A OXINIUM FEM HD 12/14 36 MM L/+8, IT WAS FOUND THE INNER POUCH HAD BEEN BROKEN AND DEFORMED. THE PIECE HAD BEEN ATTACHED TO THE LID. THE PROCEDURE WAS RESUMED, AFTER A 90-MINUTE DELAY, USING A DIFFERENT SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431285 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A PRIMARY THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTION IN THE JOINT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 52MM AND ONE (1) OXINIUM FEM HD 12/14 36 MM +0 WERE REMOVED AND NEW ONES IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 24161212 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER UNDERGOING A REVISION SURGERY ON (B)(6) 2023, PATIENT MET WITH HIS DOCTOR BECAUSE OF PAIN AND DISCOMFORT. SURGEON STATED THAT HE MAY BE GETTING ANOTHER REVISION. IT IS UNKNOWN HOW THIS ADVERSE HAS BEEN ADDRESSED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.
Patient problems: Discomfort; Pain
MAUDE report 24077656 ↗InjuryJan 15, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2023, PATIENT'S HIP DISLODGED AS IT POPPED OUT OF POCKET. PATIENT VISITED THE HOSPITAL, AND THE DEVICE WAS PUSHED BACK INTO POCKET. LATER, THE SAME INCIDENT HAPPENED WHERE THE HIP DISLODGED AGAIN AND WAS PUSHED BACK INTO POCKET. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, DURING WHICH, THE OXINIUM FEM HD 12/14 36 MM M/+4 AND R3 0 DEG XLPE ACET LNR 36MM X MM56 WERE EXCHANGED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 24077633 ↗InjuryDec 23, 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) 2025, THE PATIENT EXPERIENCED AN LUXATION. THE ADVERSE EVENT WAS ADDRESSED THROUGH A REVISION SURGERY ON (B)(6) 2025. THE PATIENT¿S CURRENT HEALTH STATUS IS STABLE.
Patient problems: Joint Dislocation
MAUDE report 23876759 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A PERIPROSTHETIC INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025. THE PATIENT WAS BEING GIVEN IV ANTIBIOTICS FOR TREATMENT OF PERIPROSTHETIC THR INFECTION. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 23838081 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER UNDERGOING A THR REVISION SURGERY ON (B)(6) 2023 DUE TO A BROKEN TOTAL HIP ARTHROPLASTY ALONG WITH SEVERE METALLOSIS, THE PATIENT SUFFERED FROM DISLOCATION OF LEFT HIP ARTHROPLASTY. THIS ADVERSE EVENT WAS ADDRESSED BY DOING A CLOSED REDUCTION ON (B)(6) 2023, DURING WHICH, UNDER GENERAL ANESTHESIA, THE HIP WAS EXAMINED. THE HIP WAS SLIGHTLY SHORTENED AND EXTERNALLY ROTATED. SLIGHTLY FLEXION WAS DONE, DISTAL TRACTION APPLIED, AND IT WAS INTERNALLY ROTATED AND THE HIP REDUCED. AT THIS POINT, IT WAS STABLE AFTER REDUCTION. THERE WERE NO COMPLICATIONS.
Patient problems: Joint Dislocation
MAUDE report 23622106 ↗InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING A TOTAL HIP REPLACEMENT SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THE EVENT WAS TREATED WITH AN ILIOPSOAS TENDON RELEASE ON (B)(6) 2025, DURING WHICH ONE OXINIUM FEM HD 12/14 36 MM +0 AND ONE R3 20 DEG XLPE ACET LNR 36MM X 52MM WERE EXCHANGED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23501340 ↗
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.
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