JOURNEYRecalls & reported problems across all models
Smith & Nephew, Inc. · 566 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one JOURNEY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6,250
- Deaths reported
- 2
- Injuries reported
- 2,495
- Recalls
- 4
We found 566 models of JOURNEY by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 6,250 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2015 and Sep 29, 2026 — classified as 2 deaths, 2,495 injuries, 3,753 malfunctions.
The most frequently reported specific device problem is “Break” (2,329 reports).
4 FDA recall records name at least one of these models by its device identifier, 3 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
JOURNEY 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.
- Sep 27, 2023Open, Classified
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Z-0158-2024 · Root cause: Component change control · Recall details · FDA record ↗
- Sep 27, 2023Open, Classified
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Z-0157-2024 · Root cause: Component change control · Recall details · FDA record ↗
- Mar 27, 2023Open, Classified
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
Z-1393-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 19, 2022Terminated
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
Z-1099-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported JOURNEY problems
Device problems
- Break2,329
- Fracture1,209
- Adverse Event Without Identified Device or Use Problem745
- Insufficient Device Problem Information691
- Crack350
- Detachment of Device or Device Component149
- Loose or Intermittent Connection99
- Material Fragmentation82
Patient problems
- No Clinical Signs, Symptoms or Conditions3,335
- Injury698
- No Consequences Or Impact To Patient404
- No Known Impact Or Consequence To Patient356
- Pain310
- Unspecified Infection277
- Failure of Implant244
- No Patient Involvement201
JOURNEY models
566 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- JOURNEY 74012812PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- JOURNEY 74011857PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- JOURNEY 74012821ORTHOPEDIC MANUAL SURGICAL INSTRUMENT295 reports
- JOURNEY 74011821ORTHOPEDIC MANUAL SURGICAL INSTRUMENT279 reports
- JOURNEY 74012415PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012416PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74011711PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER134 reports
- JOURNEY 74012414PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- JOURNEY 74018901PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 reports
- JOURNEY 74012417PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER103 reports
- JOURNEY 74012418PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER90 reports
- JOURNEY 71935180TEMPLATE89 reports
- JOURNEY 74018603ORTHOPEDIC MANUAL SURGICAL INSTRUMENT87 reports
- JOURNEY 74018911PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER79 reports
- JOURNEY 74022125PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall27 reports
- JOURNEY 74018608PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER67 reports
- JOURNEY 74027262PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall16 reports
- JOURNEY 74012831PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER62 reports
- JOURNEY 74027231PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER54 reports
- JOURNEY 74029262PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- JOURNEY 74026178PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- JOURNEY 74012413PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER51 reports
- JOURNEY 74022213PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER48 reports
- JOURNEY 74022114PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER46 reports
- JOURNEY 71441353PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER45 reports
- JOURNEY 74024835PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER42 reports
- JOURNEY 74012455PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER41 reports
- JOURNEY 74022223PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER40 reports
- JOURNEY 74012514PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER38 reports
- JOURNEY 74012419PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER38 reports
- JOURNEY 74027241PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER35 reports
- JOURNEY 74027242PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER30 reports
- JOURNEY 74024832PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER29 reports
- JOURNEY 74022216PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER28 reports
- JOURNEY 74022224PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER28 reports
- JOURNEY 74023251PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER28 reports
- JOURNEY 74022124PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 death27 reports
- JOURNEY 74022126PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER27 reports
- JOURNEY 74022116PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER26 reports
- JOURNEY 74022214PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER26 reports
- JOURNEY 74033616PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER26 reports
- JOURNEY 74027261PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER25 reports
- JOURNEY 74021164PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER25 reports
- JOURNEY 74021155PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER25 reports
- JOURNEY 74022225PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER25 reports
- JOURNEY 74022115PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER24 reports
- JOURNEY 74027271PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER24 reports
- JOURNEY 74018610PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER24 reports
- JOURNEY 74012456PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER24 reports
- JOURNEY 74027232PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER23 reports
- JOURNEY 74021165PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER23 reports
- JOURNEY 74035211PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- JOURNEY 74027252PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- JOURNEY 74012645PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- JOURNEY 74035222PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- JOURNEY 74035271PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- JOURNEY 74027281PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- JOURNEY 74035221PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER19 reports
- JOURNEY 74035231PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER19 reports
- JOURNEY 74022117PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER19 reports
- JOURNEY 74023271PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER19 reports
- JOURNEY 74027251PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER18 reports
- JOURNEY 74022123PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- JOURNEY 74021156PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- JOURNEY 74016421BIT, DRILL17 reports
- JOURNEY 74023261PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- JOURNEY 74022118PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 death16 reports
- JOURNEY 74022127PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- JOURNEY 74027233PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- JOURNEY 74022215PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- JOURNEY 74022217PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- JOURNEY 74035241PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- JOURNEY 71422265PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER15 reports
- JOURNEY 71436133PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER15 reports
- JOURNEY 74035261PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- JOURNEY 74022128PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- JOURNEY 74023231PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- JOURNEY 74012576PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 74035272PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 74021157PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 74021153PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 74022226PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 74022212PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 74022222PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 74022227PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 74024838PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- JOURNEY 71422251PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER13 reports
- JOURNEY 74035281PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- JOURNEY 74033651PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- JOURNEY 74021167PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- JOURNEY 74021166PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- JOURNEY 74021163PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- JOURNEY 74021154PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- JOURNEY 71422261PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER12 reports
- JOURNEY 74027263PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- JOURNEY 74027234PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- JOURNEY 74033661PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- JOURNEY 74025621PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- JOURNEY 74023281PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
Recent JOURNEY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
It was reported that, during a TKA surgery, one (1) JRNY II CR LKG FEM IMP BUMPER LT was broke on impact, all pieces were located. 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 50927191 ↗MalfunctionSep 19, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832703 ↗MalfunctionSep 15, 2026Fracture
It was reported that, during a TKA surgery, one (1) JOURNEY FEM IMPACT BUMPER LT broke during impaction. 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 50766182 ↗MalfunctionSep 9, 2026Break
It was reported that, during a TKA surgery, one (1) JOURNEY FEM IMPACT BUMPER LT broke upon impaction. The procedure was resumed, without any delay, using a equivalent S+N back-up product. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693642 ↗MalfunctionAug 27, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component
It was reported that, during a TKA surgery, one (1) JOURNEY DCF AP FEM CUT BLK 5 had a screw on the back of the AP cutting block come out while the AP cutting block was being removed with the universal extractor tool. The screw was recovered. The surgeon also reported that two pegs on the cutting block extended through the 1 and 2 cut slots and interfered with the cutting process, preventing a complete cut from being made. 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 50488492 ↗MalfunctionAug 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304618 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304098 ↗MalfunctionAug 17, 2026Detachment of Device or Device Component
It was reported that, during TKA surgery, cutting block knob of (one) 1 JOURNEY DCF AP FEM CUT BLK 7came off. 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 50268758 ↗MalfunctionAug 14, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255426 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246130 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
It was reported that, during a TKA, when cutting the femur, one (1) JOURNEY DCF AP FEM CUT BLK 5 had disassembled/broken down. Scrub nurse ensured central lock (dot to dot) was locked prior to handing to Surgeon. Finished the cuts but had to use a rongeur to take the parts out bit by bit. The procedure was resumed, after a non-significant delay, using the same device. No further complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225105 ↗MalfunctionAug 6, 2026Break
It was reported that, during a TKA surgery, the JOURNEY ART ISRT ASSM TOOL was broken. 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 50160813 ↗MalfunctionJul 27, 2026Delivered as Unsterile Product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50029244 ↗InjuryJul 20, 2026Fracture
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED KNEE INSTABILITY. FURTHER EVALUATION REVEALED THAT THE POST OF A JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9 MM WAS BROKEN. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE BROKEN JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9 MM WAS REMOVED AND REPLACED WITH A 9 MM SIZE 5-6 CONSTRAINED INSERT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 25884140 ↗MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785268 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- 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
- 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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