JOURNEY 74035222Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885556156780), received between May 29, 2020 and May 4, 2022 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Crack” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10MM LEFT BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282391 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT THE JRNY II BCS ART ISRT TRL SZ 1-2 10MM LT BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14225337 ↗
• MalfunctionDec 28, 2021Crack; Crack

  IT WAS REPORTED THAT A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10MM LEFT IS CRACKED/CHIPPED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13093472 ↗
• MalfunctionDec 28, 2021Crack; Crack

  IT WAS REPORTED THAT A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10MM LEFT IS CRACKED/CHIPPED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13093078 ↗
• 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 12861521 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED 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 12487970 ↗
• MalfunctionApr 20, 2021Break; Break

  (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. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693252 ↗
• 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 (B)(4), THE JOURNEY II BCS ARTICULAR INSERT SIZE 1-2 9 MM RIGHT (B)(4), TWO UNIVERSAL INSERT SPACER SIZE 1-2 18 MM (B)(4), JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER RIGHT (B)(4), JOURNEY UNI TIBIA INSERT SIZE 1-2/8 MM (B)(4), JOURNEY UNI TIBIA TRIAL SIZE 5-6/8 MM (B)(4), JOURNEY UNI TIBIA TRIAL SIZE 3-4/8 MM (B)(4), THREE HONEYCOMB (B)(4), JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM RIGHT (B)(4), THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 10 MM LEFT (B)(4) AND THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT (B)(4) WERE NOTICED CRACKED. TWO COMPRESSION SCREW HEX DRIVER (B)(4) AND SCREWDRIVER RELEASE HANDLE (B)(4) WERE NOTICED BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593417 ↗
• MalfunctionMar 24, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING INSPECTION, IT WAS NOTICED THAT TWO JRNY II BCS ART ISRT TRL HAD CRACKS/GOUGES IN PLASTIC. THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566382 ↗
• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE HAS CHIPS/GOUGES IN PLASTIC. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326722 ↗
• MalfunctionDec 21, 2020Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050989 ↗
• MalfunctionDec 21, 2020Crack; Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050971 ↗
• MalfunctionDec 21, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050945 ↗
• InjuryNov 4, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, INSTRUMENTS INSIDE THE PATIENT, THE INSERT TRIAL WAS BROKEN. UNKNOWN HOW THE PROCEDURE FINISHED. SURGICAL DELAY LESS THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10789397 ↗
• MalfunctionJul 24, 2020Break; Crack; Break; Crack

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

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

  MAUDE report 10318380 ↗
• 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 10318379 ↗
• 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 10194334 ↗
• 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 10194321 ↗
• 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 10103189 ↗
• 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 10102315 ↗

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