JOURNEY 74011856Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER LEFT · Class 2
All models of JOURNEY (566)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Journey II femoral impactor bumper has 438 adverse event reports, with 70 injuries and no deaths. The reports mostly describe the bumper cracking or breaking during knee replacement surgery, sometimes when it was struck with a mallet. There were 15 reports in the last 12 months, compared with 35 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 438
- Deaths reported
- 0
- Injuries reported
- 70
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 438 adverse event reports that list this exact device (DI 00885556422878), received between Dec 10, 2018 and Sep 29, 2026 — classified as 70 injuries, 368 malfunctions.
The most frequently reported specific device problem is “Break” (241 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break241
- Fracture169
- Crack31
- Naturally Worn4
- Material Twisted/Bent3
- Connection Problem2
- Material Separation2
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions341
- No Consequences Or Impact To Patient58
- No Known Impact Or Consequence To Patient30
- No Patient Involvement9
- Foreign Body In Patient6
- Injury2
- No Information1
Recent adverse event reports
The 25 most recent of 438 reports, 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 ↗MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785268 ↗MalfunctionJul 2, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BUMPER OF ONE (1) JRNY II CR LKG FEM IMP BUMPER LT WAS CRACKED IN HALF. 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 25700304 ↗MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT, DURING A TOTAL KNEE SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE IN HALF AFTER BEING STRUCK WITH A MALLET. 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 25331482 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT FRACTURED DURING IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25307276 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE WHILE IMPACTING THE FEMUR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750569 ↗MalfunctionMar 17, 2026Break
IT WAS REPORTED THAT, DURING A TKA, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE DURING FINAL IMPACTION OF THE FINAL IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618956 ↗MalfunctionMar 12, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY A JRNY II CR LKG FEM IMP BUMPER LT WAS BROKEN DURING IMPACTION. THE BUMPER CRACKED IN HALF. NO PIECE FELL INTO THE PATIENT. 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 24579376 ↗MalfunctionMar 8, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER IMPACTING THE FEMUR, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE IN HALF. ALL PIECES WERE RETRIEVED BY HAND. 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 24542222 ↗MalfunctionJan 23, 2026Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE WHILE HAMMERING IMPLANTS INTO PLACE. BREAKAGE OCCURRED ON DISTAL FEMUR OF PATIENT, NO PIECES FELL INSIDE WOUND. THE PIECES (2) FELL ONTO DRAPES TOWARDS PATIENTS ANKLE, ALL PIECES WERE REMOVED BY HAND AND ACCOUNT FOR. IMPLANT WAS SUCCESSFULLY IMPLANTED BEFORE NOTICING THAT IMPACTOR WAS BROKEN. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME S+N DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24171708 ↗MalfunctionJan 16, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY II CR LKG FEM IMP BUMPER LT SPLIT IN HALF DURING IMPLANT IMPACTING. USED THE RIGHT BUMPER UPSIDE DOWN AS A SECONDARY IMPACTOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24102996 ↗MalfunctionJan 13, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT FRACTURED IN TWO SEPARATE PIECES WHILE IMPACTING THE FEMORAL COMPONENT. NO PIECES FELL INTO THE WOUND. X-RAYS ARE NOT AVAILABLE. 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 24062607 ↗MalfunctionJan 9, 2026Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRNY II CR LKG FEM IMP BUMPER LT AND A JOURNEY FEM IMPACT BUMPER LT CHIPPED DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. ALSO THE JRNY II IMPACTING FINISHING TRAY AND THE UNIVERSAL STANDARD LID ARE BOTH BENT. 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 24029716 ↗MalfunctionNov 24, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, DURING HAMMERING ONE (1) JRNY II CR LKG FEM IMP BUMPER LT FRACTURED. THE SURGEON COLLECTED THE BROKEN PIECES BUT APPROX. 2MM FRAGMENT WAS MISSING. X-RAY INSPECTION WAS PERFORMED BUT THE FRAGMENT COULD NOT BE FOUND ON THE X-RAY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, THE PRODUCT WAS NO FURTHER NEEDED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631160 ↗MalfunctionNov 3, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT SPLIT INTO TWO PIECES. ALL PARTS WERE ACCOUNTED FOR AND NOT LEFT IN PATIENT. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450673 ↗MalfunctionOct 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A PLASTIC PIECE OF ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE WHEN IMPACTING THE FEMUR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23430809 ↗MalfunctionOct 28, 2025Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT TWO (2) JRNY II CR LKG FEM IMP BUMPER LT BROKE DURING FEMORAL IMPLANT IMPACTING. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408320 ↗MalfunctionOct 15, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A LEFT TKA SURGERY ONE (1) JRNY II CR LKG FEM IMP BUMPER LT SNAPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301864 ↗MalfunctionOct 1, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE JRNY II CR LKG FEM IMP BUMPER LT BROKE IN HALF WHILE IMPACTING. NO PIECES FELL INTO THE PATIENT. 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 23190844 ↗MalfunctionAug 26, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT SNAPPED CLEAN WHILE IMPACTING THE FEMUR. NO PIECES FELL IN THE WOUND. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL 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 22901302 ↗MalfunctionAug 14, 2025Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE DURING IMPACTION. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. ALSO, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804843 ↗MalfunctionJul 20, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY WHEN IMPACTING THE FEMORAL IMPLANT, THE JRNY II CR LKG FEM IMP BUMPER LT SNAPPED. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT¿S WOUND. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY, AND IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22552592 ↗MalfunctionJul 8, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE DURING NORMAL USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22445271 ↗MalfunctionJul 3, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE WHILE USING TO IMPACT. ALL BROKEN PIECES WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22391830 ↗MalfunctionJun 21, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR LKG FEM IMP BUMPER LT BROKE INTO TWO PIECES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22303880 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
- P.F.C. SIGMA 96-0781Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER236 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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