JOURNEY 74035211Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885556157183), received between May 29, 2020 and May 11, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Crack” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Fracture

  IT WAS REPORTED THAT DURING A RIGHT TKR, WHEN THE SURGEON WAS TAKING OUT A JRNY II BCS ART ISRT TRL SZ 1-2 9MM RT, IT WAS CAUGHT UNDERSIDE OF INSERT WITH SOFT TISSUE RETRACTOR AND BROKE OFF ONE BIT OF PLASTIC. THIS PLASTIC WAS RETRIEVED AND HAS BEEN KEPT WITH DAMAGED TRIAL INSERT. SURGERY WAS RESUMED WITHOUT A DELAY. IT IS UNKNOWN IF PATIENT WAS HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145487 ↗
• MalfunctionMay 6, 2022Crack; Crack

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 1-2 9MM RT WAS CRACKED. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309379 ↗
• MalfunctionApr 21, 2022Break; Break

  IT WAS REPORTED THAT, WHEN PUTTING TRAYS UP IN SPD, IT WAS FOUND THAT A JRNY II BCS ART ISRT TRL SZ 1-2 9MM RT WAS BROKEN ON THE BOTTOM. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176938 ↗
• MalfunctionMar 23, 2022Crack; Deformation Due to Compressive Stress; Crack; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 1-2 9MM RT IS CRACKED AND SCRATCHED. 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 13870246 ↗
• MalfunctionMar 1, 2022Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 9MM RIGHT IS CRACKED AND SCRATCHED. 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 13638772 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861424 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861342 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861092 ↗
• MalfunctionNov 4, 2021Degraded; Degraded

  IT WAS REPORTED THAT A JOURNEY II BCS ART INSERT TRIAL SIZE 1-2 9MM RIGHT IS CHIPPED AT THE REMOVAL SLOT. NO CASE INVOLVED, THEREFORE NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754491 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12489280 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12489279 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12489230 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488850 ↗
• 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 12291452 ↗
• MalfunctionJul 13, 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 12164336 ↗
• 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 12150976 ↗
• MalfunctionApr 20, 2021Break; Break

  REF#: (B)(4). IT WAS REPORTED THAT, THE DEVICES IN THE LIST WERE FOUND BROKEN OR CRACKED. THEY WERE USED BY CUSTOMER BEFORE DEFECT WAS FOUND IN THE WAREHOUSE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. CASE NUMBER/PART NUMBER/(B)(6) REF NUMBER CASE: (B)(4), 71674084, (B)(4). CASE: (B)(4), 71674084, (B)(4). CASE: (B)(4), 71674084, (B)(4). CASE: (B)(4), 71674084, (B)(4). CASE: (B)(4), 71674084, (B)(4). CASE: (B)(4), 71674084, (B)(4). CASE: (B)(4), 71360046, (B)(4). CASE: (B)(4), 71360046, (B)(4). CASE: (B)(4), 74035221, (B)(4). CASE: (B)(4), 74035211, (B)(4). CASE: (B)(4), 74035222, (B)(4). CASE: (B)(4), 74033616, (B)(4). CASE: (B)(4), 74033674, (B)(4). CASE: (B)(4), 110842, (B)(4). CASE: (B)(4), 71674066, (B)(4). CASE: (B)(4), 71440851, (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693247 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THE FAILURE OF DEFECTIVE DEVICES. THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM LEFT (CASE (B)(4)), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT (CASE (B)(4)), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM (CASE (B)(4)), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT (CASE (B)(4)), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM (CASE (B)(4)), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM (CASE (B)(4)), JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM (CASE (B)(4)), THREE HONEYCOMB (CASE (B)(4), CASE (B)(4)), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT (CASE (B)(4)), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT (CASE (B)(4)) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT (CASE (B)(4)) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER (CASE (B)(4)) AND SCREWDRIVER RELEASE HANDLE (CASE (B)(4)) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593423 ↗
• 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 10318369 ↗
• 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 10194292 ↗
• 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 10194273 ↗
• MalfunctionMay 29, 2020Crack; Crack

  IT WAS REPORTED THAT DURING INSPECTION OF A LOANER KIT IN WAREHOUSE THE PART WAS FOUND BROKEN/ MISSING/ DEFORMED. THE DEVICE WILL NOT BE RETURNED. THERE WAS NO HARM TO PATIENT, NO DELAY, AND THE BROKEN PIECE WAS NOT REMAIN. NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102219 ↗

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-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; 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