ANTHEMRecalls & reported problems across all models
Smith & Nephew, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 25 models of ANTHEM by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2018 and Apr 28, 2026 — classified as 39 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 ANTHEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem20
- Insufficient Device Problem Information8
- Physical Resistance/Sticking3
- Appropriate Device Problem Term/Code Not Available2
- Break2
- Connection Problem2
- Delivered as Unsterile Product2
- Difficult to Open or Remove Packaging Material2
Patient problems
- Injury16
- No Clinical Signs, Symptoms or Conditions15
- Pain4
- Thrombosis/Thrombus4
- Anemia3
- No Known Impact Or Consequence To Patient2
- Ambulation or Postural Difficulties1
- Arthralgia1
ANTHEM models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ANTHEM 71422667PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- ANTHEM 71422843PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- ANTHEM 71422668PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- ANTHEM 71422835PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- ANTHEM 71422695PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- ANTHEM 71422844PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- ANTHEM 71422805PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- ANTHEM 71422825PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- ANTHEM 71422834PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- ANTHEM 71422693PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- ANTHEM 71422694PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- ANTHEM 71422675PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Anthem 71422933PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Anthem 71422935PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- ANTHEM 71422817PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- ANTHEM 71422833PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- ANTHEM 71422674PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- ANTHEM 71422671PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- ANTHEM 71422662PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- ANTHEM 71422661PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Anthem 71422945PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Anthem 71422953PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Anthem 71422954PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Anthem 71422958PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Anthem 71422977PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent ANTHEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Positioning Failure
IT WAS REPORTED THAT, DURING A TKA, AN ANTHEM PS HF INSERT SZ 3-4 9MM DID NOT SEAT ONTO THE TIBIA. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES WITH A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25013537 ↗InjuryMar 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) ANTHEM PS HF INSERT SZ 5-6 11MM WAS EXPLANTED AND REPLACED WITH ONE (1) GII PS INSERT SZ 5-6 11MM.
Patient problems: Unspecified Infection
MAUDE report 24542205 ↗InjuryAug 14, 2025Loss of Osseointegration; Implant subsidence; Loss of Osseointegration; Implant subsidence
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED IMPLANT SUBSIDENCE AND LOOSENING IN THE TIBIA DUE TO BONE LOSS. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH OXINIUM IMPLANTS WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 22804753 ↗InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA THAT TOOK PLACE AT AN UNKNOWN TIME, A REVISION SURGERY TOOK PLACE ON (B)(6) 2024 TO EXPLANT THE ANTHEM PS HF INSERT SZ 3-4 15MM DUE TO INFECTION. THERE HAS BEEN NO REPORT OF NEW PAIN OR INFECTION ON THE PATIENT AT THIS TIME.
Patient problems: Medical device site infection
MAUDE report 20032102 ↗InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY THAT WAS PERFORMED ON (B)(6) 2023, THE PATIENT PRESENTED FEMORAL RADIOLUCENCIES ON (B)(6) 2024. IN ADDITION, THE CLINICAL STUDY IDENTIFIED OSTEOLYSIS ON THE FEMORAL COMPONENT. IT IS UNKNOWN HOW THIS EVENT WAS TREATED. CURRENT OUTCOME IS UNRESOLVED.
Patient problems: Osteolysis; Radiolucent Lines
MAUDE report 19968001 ↗MalfunctionJun 10, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING A TKA SURGERY, THE ANTHEM TIBIAL BASE PLATE SZ 3 RT COULD NOT LOCK INTO THE ARTICULAR. IT WAS CHANGED THE ARTICULAR TWO TIMES BUT STILL FACED THE SAME ISSUE. THE ANTHEM TIBIAL BASE PLATE SZ 3 RT WAS ALREADY INSERTED INTO PATIENT AND COULD NOT TAKE IT OUT. IT WAS TRIED EVERYTHING BUT STILL COULD NOT LOCK ARTICULAR COMPLETELY SO THIS EVENT COULD CAUSED REVISION IN THE FUTURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19499217 ↗InjuryDec 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A RIGHT TKA HAD BEEN PERFORMED ON (B)(6) 2022, DURING WHICH AN UNKNOWN S+N KNEE SYSTEM HAD BEEN IMPLANTED, THE PATIENT STARTED EXPERIENCING PAIN OF THE KNEE ON (B)(6) 2023. AFTER A FULL EXAMINATION OF THE KNEE, (X-RAYS, COMPUTED TOMOGRAPHY, TESTS) IT WAS FOUND THAT THE PROSTHESIS HAD BECOME LOOSE. THE PATIENT HAD STRICTLY FOLLOWED THE PHYSICIAN'S POST-OPERATIVE INSTRUCTIONS. THE SITUATION IS CURRENTLY UNRESOLVED AND THE PATIENT HAS REPORTED THAT IT IS VERY DIFFICULT FOR THEM TO WALK, AN ELBOW CRUTCH IS BEING USED TO AID AMBULATION BEFORE A REVISION SURGERY IS PERFORMED.
Patient problems: Ambulation or Postural Difficulties; Arthralgia; Joint Laxity
MAUDE report 18389812 ↗InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2018 THE PATIENT EXPERIENCED A STAPHYLOCOCCUS AUREUS IN FLUID DRAINED FROM THE LEFT KNEE ON (B)(6) 2023 . THIS ADVERSE EVENT WAS TREATED WITH MEDICATION. HOWEVER, IT REMAINS AS NOT RECOVERED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Bacterial Infection
MAUDE report 17132260 ↗InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6)2019, THE PATIENT EXPERIENCED A PULMONARY THROMBOEMBOLISM ON (B)(6)2019. THE PATIENT REQUIRED MEDICATION THERAPY AND IS NOW RECOVERED.
Patient problems: Pulmonary Embolism
MAUDE report 16632662 ↗InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY WAS PERFORMED ON THE (B)(6) 2021, THE PATIENT EXPERIENCED A DEEP VEIN THROMBOSIS (DVT) ON THE (B)(6) 2021. THIS ADVERSE EVENT WAS RESOLVED WITH MEDICATION.
Patient problems: Thrombosis/Thrombus
MAUDE report 16415110 ↗MalfunctionDec 26, 2022Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE INSIDE PACKAGING OF THE ANTHEM TIBIAL BASE PLATE SZ 5 LT WAS MELTED. THE STERILE BOX WAS NOT COMING OUT OF THE PACKAGING AND ALSO STERILITY SEEMED TO BE COMPROMISED. FINAL IMPLANT WAS DIRECTLY PICKED FROM BOX USING STERILE FORCEPS. OUTER PACKAGING OF IMPLANT WAS INTACT, AND IMPLANTS WERE STORED AND TRANSPORTED AS PER INSTRUCTIONS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (5 MINUTES), USING THE SAME DEVICE AS BACKUP IMPLANT WAS NOT AVAILABLE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16048732 ↗MalfunctionDec 8, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT, DURING A RIGHT TKA SURGERY WITH ANTHEM, THE BOX OF AN ANTHEM FEMORAL PS COCR SZ 4 RIGHT (PN 71422834, LN 21JM11188) CONTAINED A LEGION PS NP FEM SZ 3 LEFT (PN 71423223, LN 21JM14162) INSTEAD. CEMENT HAD ALREADY BEEN PLACED ON THE PROSTHESIS AT THE TIME OF THE FINDING. A BACK-UP PRODUCT WAS USED TO RESUME THE SURGERY THAT EXTENDED FOR LESS THAN 30 MIN. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15946538 ↗MalfunctionSep 9, 2022Dent in Material; Dent in Material
IT WAS REPORTED THAT AN ANTHEM FEMORAL PS COCR SZ 5 RT N HAD DENTED TRAY. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15394203 ↗MalfunctionSep 7, 2022Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE PACKAGING TRAY OF THE ANTHEM FEMORAL PS COCR SZ 3 IS DENTED. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15372018 ↗InjuryJun 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ANTHEM CR STUDY (17 4065 07); SUBJECT: 20 013; AE: 08: DVT IN LT. CALF VEIN. IT WAS REPORTED THAT, AFTER AN ANTHEM TKA SURGERY PERFORMED ON 30 SEP 2019, THE PATIENT EXPERIENCED DEEP VEIN THROMBOSIS (DVT) IN THE CALF VEIN. THIS WAS TREATED BY TAKING ELIQUIS FROM 03 OCT 2019 TO 29 DEC 2019. THIS CONDITION WAS RESOLVED ON 18 FEB 2020.
Patient problems: Thrombosis/Thrombus
MAUDE report 14671963 ↗
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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