JOURNEY II XRRecalls & reported problems across all models
Smith & Nephew, Inc. · 85 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 294
- Deaths reported
- 0
- Injuries reported
- 286
- Recalls
- 0
We found 85 models of JOURNEY II XR by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 294 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2017 and Nov 5, 2025 — classified as 286 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (126 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 XR problems
Device problems
- Insufficient Device Problem Information126
- Adverse Event Without Identified Device or Use Problem92
- Physical Resistance/Sticking36
- Break11
- Device Dislodged or Dislocated6
- Mechanical Problem6
- Patient Device Interaction Problem6
- Loosening of Implant Not Related to Bone-Ingrowth4
Patient problems
- Injury165
- Pain51
- Loss of Range of Motion19
- Unspecified Infection15
- Failure of Implant11
- No Clinical Signs, Symptoms or Conditions9
- Arthralgia7
- Inflammation7
JOURNEY II XR models
85 models, most reported first. Each model has its own page with its reports, recalls and device details.
- JOURNEY II XR 74022203PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- JOURNEY II XR 74023740PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- JOURNEY II XR 74022294PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- JOURNEY II XR 74023840PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- JOURNEY II XR 74023850PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- JOURNEY II XR 74023730PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- JOURNEY II XR 74023741PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- JOURNEY II XR 74023732PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- JOURNEY II XR 74022205PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- JOURNEY II XR 74022206PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- JOURNEY II XR 74022292PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- JOURNEY II XR 74022293PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- JOURNEY II XR 74023830PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- JOURNEY II XR 74023841PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- JOURNEY II XR 74023750PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- JOURNEY II XR 74022204PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- JOURNEY II XR 74022296PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- JOURNEY II XR 74023711PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- JOURNEY II XR 74022295PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- JOURNEY II XR 74022297PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- JOURNEY II XR 74023811PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- JOURNEY II XR 74023831PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- JOURNEY II XR 74023762PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- JOURNEY II XR 74022202PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- JOURNEY II XR 74023862PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- JOURNEY II XR 74023742PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023780PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023723PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023733PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023770PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74022208PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023810PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023820PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023822PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023842PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74023881PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74014451PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- JOURNEY II XR 74014533PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023710PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023743PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023760PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023712PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023720PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023722PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023731PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023751PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74022207PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023812PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023833PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023834PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023851PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023853PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023860PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023870PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023962PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74023979PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74024002PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74024007PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74024025PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- JOURNEY II XR 74014476PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74014526PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023761PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023763PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023772PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023781PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023752PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74022291PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023823PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023832PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023844PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023852PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023863PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023872PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023880PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023951PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023954PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023956PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023967PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023995PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74023998PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74024013PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74013977PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74013987PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74013991PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- JOURNEY II XR 74013992ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent JOURNEY II XR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 5, 2025Degraded; Degraded
IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2021, PATIENT EXPERIENCED SUBLUXATION OF THE JOURNEY XR TKA WITHOUT PREVIOUS TRAUMA. IN ADDITION, ON RADIOGRAPHY THERE IS A HIGH SUSPICION OF SEVERE PE WEAR OF THE JRNY II XR INS XLPE MED 3-4 RT 8MM. PATIENT WAS SEEN ON THE OUTPATIENT WARD ON (B)(6) 2025, WITH PROGRESSIVE COMPLAINTS OF PAIN OF THE RIGHT KNEE. A FULL REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE ADVERSE EVENT, DURING WHICH THE FEMORAL COMPONENT WAS NOTED TO BE DAMAGED WITH PRESENCE OF METALLOSIS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Arthralgia; Bone Notching; Deformity/ Disfigurement; Joint effusion; Metal Related Pathology; Subluxation
MAUDE report 23476443 ↗InjuryOct 2, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT, DURING A TKA SURGERY WITH CORI, IT WAS DIFFICULT TO SET A JRNY II XR TIB PUNCH GUIDE SZ 5-6 ON THE JRNY II XR TIBIAL PUNCH TRAY SZ 5 BECAUSE THE PUNCH GUIDE HIT THE BONE. AN ADDITIONAL BONE CUT WAS REQUIRED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 17851572 ↗InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT BICRUCIATE RETAINING TKA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT DEVELOPED PAIN AND INSTABILITY. THIS WAS TREATED ON (B)(6) 2022 BY PERFORMING A REVISION SURGERY, WHERE IT WAS DETERMINED THAT THE PATIENT HAD AN ANTERIOR CRUCIATE LIGAMENT (ACL) RUPTURE. THE SURGEON DECIDED TO KEEP THE FEMORAL AND PATELLAR COMPONENTS AND ONLY REVISE THE TIBIAL COMPONENT AND THE INSERTS. PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. PATIENT HAS STATED THAT IS STILL HAVING ISSUES WITH THE KNEE.
Patient problems: Damage to Ligament(s); Insufficient Information
MAUDE report 16935011 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN ANTERIOR CRUCIATE LIGAMENT RUPTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT ON WHICH THE TIBIAL COMPONENT WAS REPLACED. PATIENT'S OUTCOME IS PENDING.
Patient problems: Rupture
MAUDE report 16732358 ↗InjuryApr 12, 2023Migration; Migration
IT WAS REPORTED THAT DURING A CLINICAL STUDY, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED RIGHT KNEE SEVERE PAIN AND INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT. THE EXPLANTED DEVICES WERE: JRNY II XR INS XLPE MED 5-6 RT 8MM, JRNY II CR FEM COCR NP RT SZ 5, JRNY II XR BASEPLATE SZ 5 RT AND GII OVAL RESURFACING PAT 32MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant; Joint Laxity; Pain
MAUDE report 16728295 ↗InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING TKA SURGERY, THE PATIENT SUFFERED A TIBIAL INTERCONDYLAR EMINENCE FRACTURE, AFTER CEMENTATION OF THE PROSTHESIS. FRACTURE WAS FIXATED, AFTER A NON-SIGNIFICANT DELAY, WITH A SCREW DURING SURGERY. PATIENT CURRENT HEALTH STATUS IS HEALTHY.
Patient problems: Bone Fracture(s)
MAUDE report 16587415 ↗InjuryFeb 28, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE JRNY II XR BASEPLATE SZ 2 RT WAS SEATED ON TIBIA, IT DID NOT FULLY FIT. THE SURGEON, ADDITIONALLY REMOVED BONE AT PEG AND KEEL, BUT THE PROBLEM WAS NOT RESOLVED. THEN, SURGEON REMOVED BONE CEMENT, RETRIED AND KEEL PUNCH BUT THE PROBLEM WAS NOT RESOLVED EITHER. FINALLY, SURGEON WIDENED THE HOLE IN THE BONE WITH A DRILL AND THE BASEPLATE COULD BE SEATED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: Rupture
MAUDE report 16455140 ↗InjuryJan 17, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED LATERAL DISLOCATION OF THE RIGHT KNEE JOINT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2021. PER THE COLLECTED EVIDENCE RELATED TO THE SUBJECT'S CLINICAL COURSE, SHE HAS RECOVERED FROM THIS PROCEDURE.
Patient problems: Inadequate Osseointegration; Joint Dislocation
MAUDE report 16187841 ↗InjuryJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO METALLOSIS. ALSO THE PATIENT DEVELOPED SWELLING AND PAIN 10 MONTHS AFTER PRIMARY SURGERY. IN THE REVISION SURGERY DISSOCIATION OF THE JRNY II XR INS XLPE LAT 1-2 RT 8MM AND WEAR OF THE FEMORAL COMPONENT AND TIBIAL BASEPLATE WERE VERIFIED. THE EXPLANTED DEVICES WERE: JRNY II CR FEM OX NP RT SZ 2, JRNY II XR BASEPLATE SZ 2 RT, JRNY II XR INS XLPE MED 1-2 RT 8MM AND JRNY II XR INS XLPE LAT 1-2 RT 8MM. IN ADDITION, ACL WAS RUPTURED ON UNKNOWN DATE BEFORE REVISION SURGERY. PATIENT CURRENT HEALTH STATUS IS GOOD. ABRASION FOR BLACK DEPOSITS WAS USED TO TREAT THE METALLOSIS ON THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Damage to Ligament(s); Inflammation; Joint Dislocation; Metal Related Pathology
MAUDE report 16184182 ↗MalfunctionSep 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIN OF AN XR INSERT TRIAL HANDLE HAS FELL OUT, AND THE DEVICE DOES NOT STAYED TOGETHER EVEN WHEN PIN IS PUT BACK. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15466922 ↗InjuryJun 10, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED IN (B)(6) 2019 WITH A JOURNEY II XR SYSTEM, PATIENT EXPERIENCED LOOSENING IN THEIR LEFT KNEE. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE JRNY II XR BASEPLATE SZ 3 LT ALONG WITH THE INSERT TO RESOLVE THE REPORTED EVENT.
Patient problems: Joint Laxity
MAUDE report 14655074 ↗InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE TKA SYSTEM WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. THE PATIENT'S OUTCOME IS UNKNOWN.
Patient problems: Pain
MAUDE report 14548268 ↗InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE TKA SYSTEM WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. THE PATIENT'S OUTCOME IS UNKNOWN.
Patient problems: Pain
MAUDE report 14548264 ↗InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE TKA SYSTEM WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. THE PATIENT'S OUTCOME IS UNKNOWN.
Patient problems: Pain
MAUDE report 14548210 ↗InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT TORE THEIR ANTERIOR CRUCIATE LIGAMENT (ACL). THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JRNY II XR BASEPLATE SZ 4 RT WAS EXPLANTED ALONG WITH THE INSERT. THE CONDITION OF THE PATIENT IS UNKNOWN.
Patient problems: Damage to Ligament(s)
MAUDE report 14466689 ↗
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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