LEGIONRecalls & reported problems across all models
Smith & Nephew, Inc. · 446 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one LEGION model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,039
- Deaths reported
- 0
- Injuries reported
- 1,510
- Recalls
- 4
We found 446 models of LEGION by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 2,039 adverse event reports in the FDA's MAUDE database, received between Jan 6, 2016 and Jul 21, 2026 — classified as 1,510 injuries, 529 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (319 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 still open.
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
LEGION recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 2, 2024Open, Classified
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Z-0282-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
- Oct 2, 2024Open, Classified
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Z-0278-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
- Oct 2, 2024Open, Classified
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Z-0277-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
- Aug 31, 2023Open, Classified
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
Z-2621-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported LEGION problems
Device problems
- Adverse Event Without Identified Device or Use Problem648
- Insufficient Device Problem Information319
- Break249
- Fracture224
- Connection Problem52
- Device Dislodged or Dislocated49
- Loosening of Implant Not Related to Bone-Ingrowth38
- Loose or Intermittent Connection37
Patient problems
- No Clinical Signs, Symptoms or Conditions462
- Injury380
- Failure of Implant248
- Unspecified Infection224
- Pain164
- Joint Laxity128
- Insufficient Information112
- No Known Impact Or Consequence To Patient82
LEGION models
446 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- LEGION 71453231PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER88 reports
- LEGION 71453211PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER64 reports
- LEGION 71453221PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER59 reports
- LEGION 71421265PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall6 reports
- LEGION 71421164PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall5 reports
- LEGION 71453212PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER53 reports
- LEGION 71421275PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall3 reports
- LEGION 71453222PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER51 reports
- LEGION 71421163PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- LEGION 71453232PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER42 reports
- LEGION 71434465PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER41 reports
- LEGION 71434304PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER32 reports
- LEGION 71453233PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER29 reports
- LEGION 71453223PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER27 reports
- LEGION 71453201PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER25 reports
- LEGION 71453121PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- LEGION 71434306PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER21 reports
- LEGION 71453213PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- LEGION 71453111PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER19 reports
- LEGION 71453224PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- LEGION 71420523PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- LEGION 71425005PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- LEGION 71421216PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- LEGION 71434332PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER15 reports
- LEGION 71453202PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- LEGION 71453112PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- LEGION 71434404PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- LEGION 71425007PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- LEGION 71453214PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- LEGION 71421377PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER13 reports
- Legion 71442011PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER13 reports
- LEGION 71434302PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER13 reports
- LEGION 71434409PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER13 reports
- LEGION 71421385PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER12 reports
- LEGION 71453175PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- Legion 71431909PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- LEGION 71426006PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- LEGION 71421205PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- LEGION 71453174PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- LEGION 71424225PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- LEGION 71434331PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- LEGION 71425006PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- LEGION 71421214PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- LEGION 71421206PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- LEGION 71421367PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- LEGION 71453173PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- LEGION 71453177PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- Legion 71431908PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- LEGION 71434424PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- LEGION 71426005PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- LEGION 71423235PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- LEGION 71421234PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- LEGION 71453101PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- LEGION 71453284PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- LEGION 71453252PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- LEGION 71424005PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- LEGION 71426004PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- LEGION 71421207PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71421225PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71421237PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71453131PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71453234PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71453113PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71453203PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71453122PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71421305PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- LEGION 71421375PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- LEGION 71424003PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71434401PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- LEGION 71434455PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- LEGION 71420537PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- LEGION 71421208PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71423358PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- LEGION 71423236PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71421304PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- LEGION 71453278PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71453258PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71421167PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71421175PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71424046PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71434330PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- LEGION 71420551PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71425008PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71426007PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- LEGION 71423356PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- LEGION 71421217PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71421218PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71423237PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71453285PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71453277PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71421631PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- LEGION 71421364PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- LEGION 71453171PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71434487PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- LEGION 71421165PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71421174PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71424047PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71424049PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71424051PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- LEGION 71423225PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
Recent LEGION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED IN 2022, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2026, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS EXCHANGED AND THE KNEE HAD A WASHOUT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Medical device site infection
MAUDE report 25899359 ↗InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER TKR PRIMARY SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED WOUND OOZE SUGGESTIVE OF A POSSIBLE INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKR SURGERY ON (B)(6) 2026, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS EXCHANGED FOR A SIMILAR S+N BACK-UP PRODUCT. A KNEE WASHOUT WAS ALSO PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Medical device site infection
MAUDE report 25810616 ↗InjuryJul 13, 2026Fracture
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED A FRACTURE OF ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 13MM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE INSERT WAS REPLACE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 25807782 ↗MalfunctionJul 1, 2026Break
IT WAS REPORTED THAT, DURING TKA, ONE (1) LGN PSHF INSERT TRL W/JRNY SZ 7-8 9MM BROKE DURING USE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS UNKNOWN DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25686416 ↗InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY AND PATELLOFEMORAL PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE POLYETHYLENE TIBIAL INSERT WAS EXCHANGED AND REVISION OF THE PATELLA WAS PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Joint Laxity; Pain
MAUDE report 25661824 ↗InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 IN WHICH A LGN PS HIGH FLEX XLPE SZ 7-8 13MM WAS EXCHANGED AFTER DAIR. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Medical device site infection
MAUDE report 25502294 ↗MalfunctionJun 15, 2026Fracture
IT WAS REPORTED THAT, DURING A HINGE KNEE SURGERY, THE PRONGS OF TWO (2) LEGION HINGE TIBIAL STABILIZING TOOL BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25498025 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED WITH LEGION SYSTEM ON (B)(6) 2014, THE CLINICAL SUBJECT EXPERIENCE LEFT KNEE PAIN. THIS ADVERSE EVENT WAS TREATED BY SURGERY ON (B)(6) 2020. THE ADVERSE EVENT WAS RESOLVED.
Patient problems: Arthralgia
MAUDE report 25369344 ↗MalfunctionMay 31, 2026Positioning Failure
IT WAS REPORTED THAT, DURING A TKR SURGERY, WHILE ATTEMPTING TO IMPLANT THE INSERT INTO THE TIBIAL COMPONENT, ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 11MM FAILED TO LOCK PROPERLY INTO THE TIBIAL TRAY AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30MIN, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25343045 ↗InjuryMay 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED WITH LEGION AND GENESIS SYSTEM ON (B)(6) 2017, THE CLINICAL SUBJECT EXPERIENCE PAIN AND DISCOMFORT AT THE LEFT KNEE. THIS ADVERSE EVENT WAS TREATED BY SURGERY PROCEDURE IN (B)(6) 2026, IN WHICH THE ADVERSE EVENT WAS ADDRESSED. THE PATIENT RECOVERED.
Patient problems: Arthralgia
MAUDE report 25342839 ↗InjuryMay 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED STIFFNESS IN JOINT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A LGN PS HIGH FLEX XLPE SZ 3-4 15MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 25341841 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A LGN CR HIGH FLEX XLPE SZ 5-6 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO MORE INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 25316905 ↗InjuryMay 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON 2018, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING OF ONE (1) LEGION CR OXIN FEM SZ7 RT, THIS FAILURE CAUSED CHRONIC PAIN AND INSTABILITY WITHOUT INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE DEFECTIVE IMPLANTS WERE REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Aseptic loosening; Joint Laxity; Pain
MAUDE report 25310906 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE AT AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN. THIS RESULTED ON A REVISION SURGERY ON (B)(6) 26 IN WHICH THE LGN CR HIGH FLEX XLPE SZ 3-4 11MM WAS EXCHANGED. NO FURTHER DETAILS AT THIS TIME.
Patient problems: Pain
MAUDE report 25185269 ↗MalfunctionMay 14, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT, DURING A TKA, WHEN ONE (1) LGN CR HIGH FLEX XLPE SZ 1-2 10MM WAS OPENED BY CIRCULATOR PER PROTOCOL, SURGEON NOTED THAT THE STERILE PACKAGING HAD NOT BEEN SEALED PROPERLY AND WAS NOT STERILE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172464 ↗
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
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
- TWINFIX48 models · 1,450 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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