JOURNEY 74018901Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 03596010557285), received between Jun 9, 2018 and May 27, 2026 — classified as 9 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Break” (54 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Flaked

  IT WAS REPORTED THAT, DURING A CORI TKA SURGERY, CHIPS OF ONE (1) JOURNEY TIBIAL IMPL IMPACTOR CAME 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 25308201 ↗
• MalfunctionApr 5, 2026Break

  IT WAS REPORTED THAT, DURING A TKA, THREE (3) JOURNEY TIBIAL IMPL IMPACTORS CHIPPED. 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 24787019 ↗
• MalfunctionMar 26, 2026Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY TIBIAL IMPL IMPACTOR WAS CHIPPED WHEN USING ON SIZE 2 TIBIA, AS TIBIAL BASEPLATE SMALL AND IMPACTOR EASILY BOUNCES ONTO EDGE, SO GETS CHIPPED. BROKEN PIECES FELL DOWN IN PATIENTS WOUND, ALL OF THEM WERE REMOVED AND ACCOUNTED USING FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699494 ↗
• MalfunctionMar 12, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A TKA, A PIECE OF PLASTIC CHIPPED OFF OF ONE (1) JOURNEY TIBIAL IMPL IMPACTOR WHILE IN USE. 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 24581702 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) JOURNEY TIBIAL IMPL IMPACTOR BROKE. THE PROCEDURE WAS COMPLETED, AFTER NO 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 23716053 ↗
• MalfunctionNov 21, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT ONE (1) JOURNEY TIBIAL IMPL IMPACTOR BROKE UPON IMPACTION. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING AN EQUIVALENT 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 23617499 ↗
• MalfunctionNov 12, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY TIBIAL IMPL IMPACTOR BROKE UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532561 ↗
• MalfunctionOct 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY SURGERY, IT WAS NOTICED THAT A JOURNEY TIBIAL IMPL IMPACTOR STARTING TO CRUMBLE WHILE IMPACTING THE TIBIA. IT WAS CONFIRMED THAT PIECES WERE REMOVED WITH A PICKUP. 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 23384176 ↗
• MalfunctionSep 2, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A TKA, SMALL PLASTIC FLAKES CAME OFF THE JOURNEY TIBIAL IMPL IMPACTOR ONTO THE BASEPLATE AS IT WAS IMPACTED BUT THEY WERE REMOVED AND THE CASE CONTINUED. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935370 ↗
• MalfunctionMay 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TIBIA IMPLANT IMPACTION IN A TKA SURGERY, ONE (1) JOURNEY TIBIAL IMPL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074882 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY TIBIAL IMPL IMPACTOR WAS BROKEN. THE PROCEDURE WAS RESUMED, AFTER A DELAY OF LESS THAN 30 MINUTES, WITH 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 21047103 ↗
• MalfunctionDec 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY TIBIAL IMPL IMPACTOR BROKE AND A PIECE OF PLASTIC WAS OBSERVED WITHIN THE SURGICAL WOUND. THE PIECE WAS RETRIEVED USING TWEEZERS AND THE PROCEDURE HAD BEEN COMPLETED, 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 20995847 ↗
• MalfunctionOct 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHILE THE SURGEON WAS IMPACTING THE TIBIAL COMPONENT INTO THE PATIENT, THE TIP OF THE JOURNEY TIBIAL IMPL IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACKUP DEVICE AVAILABLE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547297 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY TIBIAL IMPL IMPACTOR FRACTURED. PIECES FELL INTO THE PATIENT. ALL BROKEN PIECES WERE REMOVED AND ACCOUNTED FOR. THERE WERE RETRIEVED WITH A SMALL TONSIL. THERE WAS ONLY ONE SMALL SLIVER OF PLASTIC THAT CHIPPED OFF OF THE IMPACTOR, WHICH WAS ALIGNED WITH THE REMAINING PLASTIC AND FIT APPROPRIATELY ALLOWING IT CONFIDENCE NO OTHER PIECES REMAINED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344914 ↗
• MalfunctionSep 30, 2024Degraded; Material Fragmentation; Degraded; Material Fragmentation

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JOURNEY TIBIAL IMPL IMPACTOR WAS DAMAGED AT THE SIDES DUE TO USE AND FAIR WEAR AND TEAR. THE BUMPER HAD SEVERAL SMALL PIECES FRACTURED OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338944 ↗
• MalfunctionAug 20, 2024Break; Material Fragmentation; Scratched Material; Break; Material Fragmentation; Scratched Material

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A JOURNEY TIBIAL IMPL IMPACTOR WAS SCRATCHED AND CHIPPED. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002083 ↗
• MalfunctionAug 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER INSERTING ONE (1) JOURNEY TIBIA BASE NP RT SZ 3, IT WAS FOUND THAT IT HAD A PART THAT HAD BROKEN FROM ONE (1) JOURNEY TIBIAL IMPL IMPACTOR. THE BROKEN PIECE WAS RETRIEVED, AND IT WAS DISCOVERED THAT THE TIBIAL IMPLANT IMPACTOR HAD PARTIALLY BROKEN; HOWEVER, NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991789 ↗
• MalfunctionAug 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A TKA SURGERY, IT WAS NOTICED THAT THE GREY IMPACTOR HEAD OF ONE (1) JOURNEY TIBIAL IMPL IMPACTOR WAS CHIPPING OFF DUE TO OVERUSE. THE PROCEDURE RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO PIECES FELL INSIDE THE PATIENT AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918976 ↗
• MalfunctionJun 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT, THE PLASTIC PART OF THE JOURNEY TIBIAL IMPL IMPACTOR BROKE WHILE IMPACTING. IT IS UNKNOWN IF BROKEN PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442105 ↗
• MalfunctionMay 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JOURNEY TIBIAL IMPL IMPACTOR BROKE DURING IMPACTION. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352107 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JOURNEY TIBIAL IMPL IMPACTOR BROKE. 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 18190759 ↗
• MalfunctionSep 21, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A TKA SURGERY THE JOURNEY TIBIAL IMPL IMPACTOR HEAD CRACKED. ALL PIECES RECOVERED. 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 17793958 ↗
• MalfunctionMay 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JOURNEY TIBIAL IMPL IMPACTOR BROKE IN HALF ON IMPACTION. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017338 ↗
• MalfunctionApr 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE STRIKING AREA OF THE JOURNEY TIBIAL IMPL IMPACTOR DEVICE BROKE AWAY FROM THE HANDLE OF THE IMPACTOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792390 ↗
• MalfunctionMar 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE RUBBER PIECE OF A JOURNEY TIBIAL IMPL IMPACTOR WAS CUT UP AND WAS SHEDDING PLASTIC WHEN BEING IMPACTED BY THE MALLET. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, OR IF A DELAY IN SURGERY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620934 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a