JOURNEY 74035231Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556157480), received between Dec 5, 2018 and Oct 15, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

3 other recalls cover devices cleared under the same FDA submission (K111711); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, IT WAS NOTICED THAT THE PLASTIC OF ONE (1) JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT BROKE; IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294179 ↗
• InjuryDec 11, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 3-4 9MM RIGHT WAS CHIPPING DUE TO WEAR AND TEAR, SURGEON NOTICED THAT A PIECE OF PLASTIC HAD FLAKED OFF AND WENT INTO THE WOUND. THE PIECE WAS TAKEN OUT, WOUND WAS IRRIGATED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956518 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT CHIPPING/WEAR WAS NOTICED ON A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 3-4 9MM RIGHT. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135928 ↗
• MalfunctionMay 20, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, A GII PS HI FLEX ISRT TR S1-2 11 AND G2 INS SPAC TR SZ7-8 18MM WERE DISCOLORED. A JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT IS SCRATCHED AND BROKEN. IN ADDITION, THE FOLLOWING DEVICES HAVE SCRATCHED: G2 DISH ART TR SZ3-4 9MM, GII PS HI FLEX ISRT TR S3-4 9, GII PS HI FLEX ISRT TR S5-6 9, GII PS HI FLEX ISRT TR S3-4 11, GII PS HI FLEX ISRT TR S5-6 11 AND G2 INS SPAC TR SZ5-6 13MM. AND THE FOLLOWING DEVICES WERE BROKEN: G2 INS SPAC TR SZ7-8 13MM, TWO (2) LID FOR OUTER CASES AND A SMALL OUTER CASE - 2.4. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461319 ↗
• MalfunctionMar 4, 2022Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT WAS FOUND CRACKED AND SCRATCHED. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666574 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT, THE JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252543 ↗
• MalfunctionNov 1, 2021Crack; Crack

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT IS CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729800 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 3-4 9 MM RIGHT BROKE IN HALF OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543735 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343117 ↗
• MalfunctionAug 6, 2021Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 1-2 9MM RT AND A JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT WERE CRACKED, BENT AND DAMAGED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291460 ↗
• MalfunctionAug 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKR SURGERY, A JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT] BROKE AFTER LONG CONTINUED USE. IT IS UNKNOWN IF THIS HAPPENED DURING EXTERNAL OR INTERNAL USE TO PATIENT, DURING SETUP OR INSPECTION. ALSO, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; NEVERTHELESS, THERE WAS NO SURGICAL DELAY. PATIENT WAS NOT HARMED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12275934 ↗
• MalfunctionJul 12, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT TWO JRNY II BCS ART ISRT TRL SZ 1-2 9MM RT AND ONE JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT ARE SCRATCHED AND CHIPPED. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150996 ↗
• MalfunctionJun 24, 2021Crack; Crack

  IT WAS REPORTED THAT A JOURNEY II BCS ART INSERT TRIAL SIZE 3-4 9MM RIGHT HAS A CRACK. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063794 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 3-4 9MM RT HAD A CHIP IN IT AS WELL AS SMALL PIECES COMING OFF . SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904437 ↗
• MalfunctionDec 21, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEVICES WERE FOUND CRACKED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047691 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY II BCS ARTICULAR INSERT WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10318381 ↗
• MalfunctionJun 25, 2020Crack; Crack

  IT WAS REPORTED THE DEFECTIVE DEVICE WAS FOUND DURING WAREHOUSE INSPECTION. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10194367 ↗
• MalfunctionJun 25, 2020Crack; Crack

  IT WAS REPORTED THE DEFECTIVE DEVICE WAS FOUND DURING WAREHOUSE INSPECTION. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10194352 ↗
• MalfunctionDec 5, 2018Break; Break

  IT WAS REPORTED THAT DURING TKA THE TRIAL BROKE WHEN IMPACTED INSIDE THE PATIENT. NO DELAY OR INJURY REPORTED. BACK UP AVAILABLE.

  Patient problems: No Information

  MAUDE report 8132874 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5