JOURNEY 74027252Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885556179413), received between Oct 25, 2017 and Feb 18, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A CEMENTED TOTAL RIGHT KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED PERSISTENT PAIN, AND SUFFERING PRESSURE. THE PATIENT HAD A PRIOR HISTORY OF AN ARTHROSCOPY AND CORRECTIVE OSTEOTOMY USING TOMOFIX ON (B)(6) 2023, FOLLOWED BY A SECOND ARTHROSCOPY ON (B)(6) 2024 FOR PLATE REMOVAL AND OSTEOTOMY GAP FILLING WITH HOMOLOGOUS SPONGIOSA; DESPITE THESE INTERVENTIONS, THE PATIENT WAS NEVER SYMPTOM-FREE. FOLLOWING THE TKA IMPLANTATION, MULTIPLE EXAMINATIONS AT (B)(6) WERE REPORTED AS UNREMARKABLE, BUT SUBSEQUENT EVALUATION AT (B)(6) REVEALED SIGNIFICANT KNEE INSTABILITY WITH VENTRAL DRAWER AND MARKEDLY LATERALIZED PATELLA. THE PATIENT WAS THEN SEEN ON (B)(6) 2025, AND CT IMAGING REVEALED A SUSPECTED DISLOCATION OF THE KNEE INSERT WITH INDICATION FOR OPERATIVE REVISION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM WAS EXCHANGED DUE TO DISLOCATION. THE PATIENT CURRENTLY PRESENTS WITH LIMITED WALKING DISTANCE (APPROXIMATELY 1 KM), WEIGHT-BEARING AND REST PAIN, BUT IS ABLE TO WALK WITHOUT AIDS.

  Patient problems: Deformity/ Disfigurement; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 24376992 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2025, THE PATIENT DEVELOPED A POSSIBLE INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 IN ORDER TO EXCHANGE THE JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM FOR A 5-6 9MM CONSTRAINED POLY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22056921 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED AN INFECTION. THIS WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2024, IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM WAS REPLACED WITH A CONSTRAINED INSERT, AND THE WOUND WAS WASHED OUT WITH ANTIBIOTIC. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20418528 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY THREE WEEKS AFTER A PRIMARY TKA SURGERY, PERFORMED ON (B)(6) 2023, THE PATIENT SUFFERED A FALL, WHICH RESULTED IN A QUAD TENDON RUPTURE AND SURGICAL WOUND DEHISCENCE AND INFECTION. THEREFORE, THE JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM WAS REVISED ON (B)(6) 2023, IRRIGATION AND DEBRIDEMENT WAS CARRIED OUT DUE TO THE INFECTION. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Muscle/Tendon Damage; Wound Dehiscence; Wound Infection

  MAUDE report 18338256 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED A GRINDING SENSATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY, ON (B)(6)B 2023, IN WHICH A CEMENT PARTICLE WAS FOUND IN BETWEEN THE FEMORAL COMPONENT AND THE POLY, DEBRIDEMENT, LATERAL RELEASE AND A POLY EXCHANGE WAS PERFORMED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 18302475 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED INSTABILITY ISSUES. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023 IN WHICH A JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM WAS SWAP BY A J2 5-6 CONST 11MM RT FOR A BETTER STABILITY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18188160 ↗
• InjuryNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2012, THE POST OF ONE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM BROKE OFF. A REVISION SURGERY WAS NECESSARY ON (B)(6) 2022 TO ADDRESS THIS ADVERSE EVENT. THE PATIENT'S CURRENT HEALTH STATUS HAS NOT BEEN CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 15868957 ↗
• InjuryDec 14, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED , THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY THR REVISION SURGERY AND THE INSERT WAS REPLACED WITH A 5/6X13 CONSTRAINED INSERT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005011 ↗
• InjuryDec 30, 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 INFECTION. INCISION AND DRAINAGE WERE PERFORMED, AND THE POLY WAS EXCHANGED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 11095523 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THERE WAS A REVISION SURGERY IN WHICH A JOURNEY II BCS ARTICULAR SURFACE SIZE 5-6, 10MM WAS EXCHANGED FOR A JOURNEY II CONSTRAINED ARTICULAR SURFACE SIZE 5-5, 12MM. IT WAS NOT REPORTED IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Damage to Ligament(s); Joint Laxity

  MAUDE report 10972028 ↗
• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED AN ASPIRATION PERFORMED DUE TO CONTINUED PAIN AND SWELLING AT THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 9349474 ↗
• InjuryMay 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN ARTHROSCOPY PERFORMED DUE TO PERSISTENT PAIN.

  Patient problems: Pain

  MAUDE report 8624627 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A KNEE ASPIRATION DUE TO PERSISTENT PAIN AND KNEE IS TURNING BLACK.

  Patient problems: Injury

  MAUDE report 8348097 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A KNEE ASPIRATION DUE TO PERSISTENT PAIN AND KNEE IS TURNING BLACK.

  Patient problems: Pain

  MAUDE report 8347901 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A KNEE ASPIRATION DUE TO PERSISTENT PAIN AND KNEE IS TURNING BLACK.

  Patient problems: Injury

  MAUDE report 8347812 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT IN 2017, PATIENT HAS PERSISTENT PAIN AND KNEE IS TURNING BLACK. PATIENT RECEIVED AN INJECTION TO TREAT THE PAIN.

  Patient problems: Foreign Body Reaction; Implant Pain; Inadequate Osseointegration; Inadequate Pain Relief; Injury; Loss of Range of Motion; Pain

  MAUDE report 8223563 ↗
• InjuryNov 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSERT DISASSOCIATION FROM BASEPLATE. DURING REVISION SURGERY, THE SURGEON FOUND THAT BONE CEMENT INTERVENED BETWEEN BASEPLATE AND INSERT.

  Patient problems: Injury

  MAUDE report 8100028 ↗
• InjuryNov 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SUFFERED FROM PAIN ON THE RIGHT KNEE. REVISION SURGERY PERFORMED. NO DELAY, ADDITIONAL INJURIES OR BACK UP REPORTED.

  Patient problems: Injury

  MAUDE report 8066775 ↗
• InjurySep 5, 2018Device Slipped

  IT WAS REPORTED THAT THE SURGEON STATED THE "TIBIAL WAS LOOSE" AND CHOSE TO REVISE THE TIBIAL COMPONENT.

  Patient problems: No Code Available

  MAUDE report 7847120 ↗
• InjuryAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE THE INSERT TO CHECK AFFECTED AREA OF RUPTURED SUTURE THAT WAS CAUSED BY PATIENT FALL.

  Patient problems: Injury

  MAUDE report 7806818 ↗
• InjuryFeb 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT FELL POST OP AND TORE QUAD TENDON. PROCEDURE TO FIX QUAD INCLUDED POLY SWAP.

  Patient problems: Injury

  MAUDE report 7262347 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A SURGICAL PROCEDURE WAS PERFORMED TO RESOLVE KNEE EFFUSION AND PAIN.

  Patient problems: Injury; Joint Swelling

  MAUDE report 6978027 ↗

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-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-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