JOURNEY 74027261Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885556177969), received between Oct 6, 2017 and Jul 20, 2026 — classified as 22 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

4 other recalls cover devices cleared under the same FDA submission (K111711, K230653); 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED KNEE INSTABILITY. FURTHER EVALUATION REVEALED THAT THE POST OF A JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9 MM WAS BROKEN. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE BROKEN JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9 MM WAS REMOVED AND REPLACED WITH A 9 MM SIZE 5-6 CONSTRAINED INSERT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 25884140 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKA SURGERY ON (B)(6) 2026, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection; Post Operative Wound Infection

  MAUDE report 24441819 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JRNY BCS PAT BICONVEX 23 MM STD AND ONE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM WERE REVISED AND REPLACED WITH S+N DEVICES. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Pain

  MAUDE report 22708901 ↗
• MalfunctionAug 24, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THERE WAS A BUBBLE AT THE BOTTOM OF A JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM; AS A RESULT, THE INSERT'S BOTTOM WAS NOT FLAT AND COULD NOT LOCK IN. THE PROCEDURE WAS RESUMED BY USING A BACKUP POLY INSERT, IT IS UNKNOWN IF THIS ISSUE CAUSED ANY DELAYS. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17614612 ↗
• MalfunctionAug 22, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, IT WAS NOTICED ON A JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM THAT THE OUTER SOFT PLASTIC PACKAGING ON THE BOX WAS INTACT. THE PEEL SEAL WAS INTACT. THE PLASTIC WAS OPENED AND THE SEAL REMOVED, THE BOX WAS OPENED. INSIDE THE BOX, THE PROTHESIS OUTER PACKAGE AND INNER PACKAGE WERE OPEN. THE PROSTHESIS WAS NOT STERILE AND COULD NOT BE USED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599083 ↗
• InjuryMar 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED LAXITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM WAS EXPLANTED AND EXCHANGE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16570455 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN DUE TO SUSPECTED IMPINGEMENT NEAR THE POPLITEUS MUSCLE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, WHERE THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM WAS EXPLANTED AND EXCHANGED. CURRENT HEALTH STATUS OF PATIENT US UNKNOWN.

  Patient problems: Pain

  MAUDE report 15237388 ↗
• MalfunctionDec 23, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A JOURNEY II BCS XLPE ART INSERT SIZE 5-6 LEFT 9MM FAILED TO BE INSERTED IN NORMALLY. SURGERY WAS RESUMED, AFTER A 1 HOUR 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 13080405 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A POSSIBLE INFECTION. HE WAS DEBRIDED, RINSED OUT, AND POLY WAS SWAPPED FOR A NEW ONE.

  Patient problems: Unspecified Infection

  MAUDE report 11061159 ↗
• InjuryNov 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. UNKNOWN IF OCCURRED A SURGICAL DELAY. UNKNOWN PATIENT'S OUTCOME.

  Patient problems: Pain

  MAUDE report 10913541 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN AND AN INCREASING SYNOVIAL MEMBRANE. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE INSERT. SURGEON STATED THAT IMPLANTS WERE NOT DEFECTIVE. IT IS UNKNOWN IF EVENT WAS RESOLVED.

  Patient problems: Pain; Synovitis

  MAUDE report 10689390 ↗
• InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF FEMORAL COMPONENT AND PAIN. PRIMARY OPERATION WAS PERFORMED ON (B)(6) 2019. THERE WAS NO PROBLEM AT THAT TIME, AND THERE WAS NO FINDINGS OF INFLAMMATION LIKE ARTHROFIBROSIS, NOR INFECTION. ON (B)(6) 2020 REVISION SURGERY WAS PERFORMED AND FEMORAL COMPONENT, TIBIAL COMPONENT, INSERT AND PATELLA WERE REMOVED. THE FEMORAL COMPONENT WAS EASY TO REMOVE, BUT THE OTHER COMPONENTS WERE FIXED WELL. THERE WAS A LITTLE RESIDUE OF CEMENT ONTO NON-ARTICULAR SURFACE OF FEMORAL COMPONENT. PATIENT OUTCOME IS GOOD. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 10230732 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 21 MONTHS AGO THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT FOR HER LEFT KNEE AND SHE IS STILL IN INCREDIBLE PAIN, IT OFTEN FEELS VERY WARM AND VERY TIGHT. THERE IS A LARGE INDENTATION ON THE BOTTOM LEFT OF HER KNEE, AND A "KNIFE STABBING" AND "OUT OF PLACE" SENSATION. THE DOCTOR SAID IT WAS THE IMPLANT OPENING UP WHEN BENT. THE PAIN IS OFTEN BELOW THE KNEECAP. THE PATIENT IS USING A PATELLA BRACE, KINESIO TAPE, PHYSICAL THERAPY AND PUTTING ICE ON THE KNEE.

  Patient problems: Pain

  MAUDE report 10199475 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION 9 DAYS POST-OPERATION. SURGEON PERFORMED AN INCISION AND DRAINAGE. POLY WAS CHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 9659095 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 9484035 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DEBRIDEMENT WAS PERFORMED DUE TO INFECTION, BUT IT DIDN'T IMPROVE THE PATIENT'S HEALTH RESULTING IN A REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 9281430 ↗
• InjuryOct 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. DURING AN ARTHROSCOPIC KNEE SURGERY DUE TO PAIN IT WAS NOTICED THAT THE INSERT PRESENTED A DIFFUSE PITTING ON THE SURFACE. IT WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 9168989 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT LOWER EXTREMITY SWELLING AND CELLULITIS AND WAS RESOLVED WITH UNSPECIFIED REMEDIAL THERAPY.

  Patient problems: Cellulitis; Swelling

  MAUDE report 8834598 ↗
• InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR REVISED A COCR JOURNEY II BCS FEMUR TO AN OXINIUM LEGION REVISION FEMUR WITH COUPLER AND STEM. PATIENT WAS STIFF (ONLY 50 DEGREES RANGE OF MOTION) AND HAD A LOT OF PAIN. DR HAD ALREADY MANIPULATED THE KNEE ONCE (DATE UNKNOWN).

  Patient problems: Pain

  MAUDE report 8460193 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED FOR EXCISION OF HYPERTROPHIC SCAR.

  Patient problems: Pain

  MAUDE report 7389343 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO A SUBLUXED DISLOCATED LEFT PATELLA.

  Patient problems: Joint Dislocation

  MAUDE report 7138080 ↗
• InjuryOct 25, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVSION SURGERY. AFTER PRIMARY SURGERY PATIENT CAME BACK WITH A DRAINING WOUND AND POLY WAS EXCHANGED.

  Patient problems: No Code Available

  MAUDE report 6975601 ↗
• InjuryOct 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY/POLY EXCHANGE DUE INFECTION THAT RESULTED IN SIGNIFICANT LEFT KNEE PAIN AND SWELLING.

  Patient problems: Pain; Swelling; Unspecified Infection

  MAUDE report 6971167 ↗
• InjuryOct 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR MONTHS AFTER A LEFT TKA THE PATIENT REQUIERED A LEFT KNEE MANIPULATION UNDER ANESTHESIA BECAUSE HE HAD DIFFICULTY REGAINING HIS PREOPERATIVE RANGE OF MOTION.

  Patient problems: No Code Available

  MAUDE report 6950383 ↗
• InjuryOct 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY IN WHICH THE POLY INSERT WAS EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 6921442 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. 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-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5