JOURNEY II UNIRecalls & reported problems across all models
Smith & Nephew, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 8 models of JOURNEY II UNI by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2020 and Nov 3, 2025 — classified as 6 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Fracture” (24 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 JOURNEY II UNI problems
Device problems
- Fracture24
- Break16
- Adverse Event Without Identified Device or Use Problem3
- Crack2
- Material Twisted/Bent2
- Detachment of Device or Device Component1
- Material Fragmentation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Known Impact Or Consequence To Patient3
- Joint Dislocation1
- Joint Laxity1
- Loss of Range of Motion1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
- Unspecified Infection1
JOURNEY II UNI models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- JOURNEY II UNI 74016422ORTHOPEDIC MANUAL SURGICAL INSTRUMENT35 reports
- JOURNEY II UNI 74036039PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- JOURNEY II UNI 74026026PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- JOURNEY II UNI 74016463OSTEOTOME2 reports
- JOURNEY II UNI 74026024PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II UNI 74036038PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II UNI 74036040PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- JOURNEY II UNI 74036050PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent JOURNEY II UNI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PARTIAL KNEE REPLACEMENT SURGERY, THE METAL PIECE OF ONE (1) 3.5MM LOCKING HEX T-HANDLE BROKE OFF INSIDE THE LOCKING HOLE OF THE LM/RL TIBIA RESECTION GUIDE STANDARD. THE PROCEDURE WAS COMPLETED WITH ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23460456 ↗InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A TKA, PATIENT CONTRACTED A VERY AGGRESSIVE VIRUS THAT INFECTED HER LEG. PATIENT COULD NOT SLEEP DUE TO THE PAIN AND THE INFECTION OF THE PROTHESIS. THIS CAUSED PERMANENT DAMAGE SUCH AS THE PATELLA OUT OF AXIS. IN ADDITION, THE BLOOD VALUES WERE 16 TIMES ABOVE THE TOLERANCE. IT IS UNKNOWN HOW THIS ADVERSE EVENT HAS BEEN ADDRESSED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23263118 ↗MalfunctionOct 3, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING AN UNICONDYLAR KNEE REPLACEMENT SURGERY WHILE TRYING TO UNLOCK ONE (1) RM/LL TIBIA RESECTION GUIDE STANDARD TO ADJUST THE CUT DEPTH, ONE (1) 3.5MM LOCKING HEX T HANDLE BROKE INSIDE THE LOCKING SYSTEM OF THE CUT BLOCK. THE PIECE THAT BROKE OFF REMAINED INSIDE THE TIBIAL CUT BLOCK. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23216025 ↗MalfunctionJul 20, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING UKA SURGERY, ONE (1) JRNY II UK MED INSERT TRIAL SZ 5-6 8MM WAS CHIPPED DURING IMPLANTATION. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY, AND IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22552557 ↗MalfunctionJul 19, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING UKA SURGERY, ONE (1) JRNY II UNI MED INSERT TRIAL SZ 5-6 9MM WAS CHIPPED DURING IMPLANTATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22551555 ↗MalfunctionApr 15, 2025Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING UKR SURGERY, ONE (1) 3.5MM LOCKING HEX T-HANDLE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21845743 ↗MalfunctionMar 26, 2025Break; Break
IT WAS REPORTED THAT, DURING AN UKA SURGERY, THE SCREW OF ONE (1) RM/LL TIBIA RESECTION GUIDE STANDARD COULD NO LONGER BE ADJUSTED, AND MORE FORCE WAS APPLIED CAUSING ONE (1) 3.5MM LOCKING HEX T-HANDLE TO BREAK. NO PARTS FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING THE SAME DEVICES, AND NO INJURIES WERE REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21702228 ↗MalfunctionOct 22, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A UKR SURGERY, THE 3.5MM LOCKING HEX T-HANDLE TIP BROKE OFF. THE PATIENT IS FINE AND ALL PARTS WERE RETRIEVED. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO DELAY OR INJURY TO PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20501886 ↗MalfunctionOct 13, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A UKA, THE TIP OF A 3.5MM LOCKING HEX T-HANDLE BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20436188 ↗InjuryOct 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT UKA PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2020 DUE TO LEFT MEDIAL KNEE PRIMARY OSTEOARTHRITIS, THE PATIENT EXPERIENCED MECHANICAL SYMPTOMS OF THE LEFT KNEE PROSTHESIS WITH CATCHING AND LOCKING SENSATION AND THE PRESENCE OF A LOOSE BODY (UNKNOWN TISSUE). THE PATIENT UNDERWENT ARTHROSCOPIC DEBRIDEMENT ON (B)(6) 2022 WITH REMOVAL OF THE LOOSE BODY. THE PROCEDURE WENT UNEVENTFULLY AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.
Patient problems: Loss of Range of Motion
MAUDE report 20435203 ↗InjuryOct 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT UKA PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2019 DUE TO OSTEOARTHRITIS, THE PATIENT SUSTAINED LEFT KNEE INTERNAL PROSTHESIS INSTABILITY WITH PATELLA DISLOCATION ON (B)(6) 2021. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. 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: Joint Dislocation; Joint Laxity
MAUDE report 20435189 ↗MalfunctionOct 3, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY (JII UK), ONE (1) JRNY II UNI MED INSERT TRIAL SZ 5-6 9MM WAS FOUND WITH SIGNIFICANT DAMAGED AND FRACTURED BY THE DOCTOR, AFTER TRIAL REDUCTION. IT IS UNKNOWN WHEN THE BREAKAGE OF THE TRIAL OCCURRED, BUT THEY DO NOT BELIEVE ANY PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359095 ↗MalfunctionJul 23, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN UNICONDYLAR KNEE REPLACEMENT SURGERY, THE TIP OF AN SCREW OF THE 3.5MM LOCKING HEX T-HANDLE FRACTURED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A SMITH + NEPHEW BACK UP DEVICE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806792 ↗MalfunctionJul 18, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF ONE (1) KEEL PUNCH BROKE, IT WAS GOUGED. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19772144 ↗MalfunctionJun 3, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING THE PREPARATION OF THE TIBIA IN A TKA SURGERY, A KEEL PUNCH BROKE. THE FRAGMENT WAS RETRIEVED FROM THE BONE WITH FORCEPS AND DISCARDED IN THE SHARP BIN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO OTHER COMPLICATION WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19454409 ↗
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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