JOURNEY 74022123Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556170311), received between May 3, 2017 and Nov 4, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE ON (B)(6) 2015, THE PATIENT STARTED EXPERIENCING PATELLOFEMORAL PAIN AND MALTRACKING OF THE PATELLA ON (B)(6) 2016. THIS ADVERSE EVENT WAS ADDRESS BY A REVISION SURGERY ON (B)(6) 2021. IN THIS SURGERY, A JRNY II BCS FEMORAL OXIN LT SZ 3, A JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM AND A JOURNEY TIBIA BASE NP LT SZ 4 WERE EXPLANTD. NO FURTHER DETAILS AT THIS TIME.

  Patient problems: Deformity/ Disfigurement; Insufficient Information; Pain

  MAUDE report 23471664 ↗
• InjuryOct 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY PERFORMED ON (B)(6) 2024 PATIENT STARTED TO EXPERIENCE PAIN AND DECREASED RANGE OF MOTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY PERFORMED ON (B)(6) 2025 IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 1-2 LT 9MM WAS EXPLANTED. SURGEON THINKS THAT THIS EVENT WAS CAUSED BY PATIENT CHARACTERISTICS AND THEREFORE CONCLUDED IT WAS NOT A PRODUCT FAILURE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Arthrofibrosis; Loss of Range of Motion; Pain

  MAUDE report 23234206 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE REPLACEMENT SURGERY PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED A LOCKING OF THE LEFT KNEE WHEN ATTEMPTING TO CYCLE. THE KNEE LOCKED WHEN THE FOOT PEDAL WAS AT THE TOP OF ITS TRAVEL, AND THE PATIENT WAS NO LONGER ABLE TO CYCLE. NO TREATMENT WAS PROVIDED, AND THE ADVERSE EVENT HAS NOT RESOLVED.

  Patient problems: Joint locking

  MAUDE report 22710603 ↗
• InjuryDec 6, 2022Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED LOOSENING OF ONE (1) JRNY II BCS FEMORAL OXIN LT SZ 3, ONE (1) JOURNEY TIBIA BASE NP LT SZ 3, ONE (1) GNS II RESURF PAT 32MM AND ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM. THIS EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15923367 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CORI-ASSISTED TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A FEMUR FRACTURE NEAR CORI PIN INSERTION SITE. THIS ADVERSE EVENT WAS TREATED BY PERFORMING AN ADDITIONAL SURGERY ON (B)(6) 2022, IN WHICH NONE OF THE DEVICES WAS EXPLANTED. THE FRACTURE, WHICH OCCURRED ONLY ON THE PATIENT¿S FEMUR, WAS FIXED WITH COMPETITOR¿S NAIL. THE FEMORAL COMPONENT DID NOT BREAK. THE ONLY CAUSE OF THE MENTIONED ADDITIONAL SURGERY WAS DETERMINED TO BE THE FEMUR FRACTURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Vertebral Fracture

  MAUDE report 15519119 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2020, THE PATIENT EXPERIENCED POST-OP INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO SOLVE THIS PROBLEM. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14431095 ↗
• InjuryDec 14, 2021Adverse 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 (B)(6) 2021, THE PATIENT EXPERIENCED INFECTION, SWELLING AND FEVER FROM PRIMARY SURGERY. THIS ADVERSE EVENT WAS SOLVED BY DOING A REVISION SURGERY TO EXTRACT JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM ((B)(4)), JRNY II BCS FEMORAL OXIN LT SZ 3 ((B)(4)), JOURNEY TIBIA BASE NP LT SZ 3 ((B)(4)) AND GNS II BICONVEX PAT 23MM ((B)(4)) ON (B)(6) 2021 AND IMPLANT COMPETITOR IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 13002301 ↗
• InjuryDec 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY SURGERY, A METAL FRAGMENT WAS FOUND IN PATIENT'S INCISION. THE METAL FRAGMENT WAS SUCCESSFULLY REMOVED. IT IS UNKNOWN WHICH PRODUCT THIS METAL FRAGMENT CAME FROM AS THERE WERE NO BREAKAGE ON SURGICAL INSTRUMENTS; THEREFORE, IT MIGHT HAVE COME FROM EITHER JRNY II BCS FEMORAL OXIN LT SZ 3 OR JOURNEY TIBIA BASE NP LT SZ 2. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911925 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REVISE THE JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3 (B)(4), THE JOURNEY TIBIAL BASEPLATE NONPOROUS LT SZ 2 (B)(4), THE JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 1-2 LEFT (B)(4)) 10MM AND THE GENESIS II OVAL RESURFACING PATELLAR 29MM (B)(4). THE REASON OF THE REVISION IS UNKNOWN, AS WELL AS THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 12543599 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REVISE THE JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3 (B)(4), THE JOURNEY TIBIAL BASEPLATE NONPOROUS LT SZ 2 (B)(4), THE JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 1-2 LEFT ((B)(4)) 10MM AND THE GENESIS II OVAL RESURFACING PATELLAR 29MM (B)(4)). THE REASON OF THE REVISION IS UNKNOWN, AS WELL AS THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 12543543 ↗
• MalfunctionOct 4, 2019Break; Break

  IT WAS REPORTED THAT AFTER THE IMPLANTATION, A FOREIGN PARTICLE WAS FOUND, AND IT WAS PICKED UP FROM THE PATIENT BODY. IT WAS UNKNOWN IF THE PARTICLE WAS CAUSED BY THE INSTRUMENTS OR IMPLANTS.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9158568 ↗
• InjuryJul 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACED TO LEGION PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 8787782 ↗
• InjuryApr 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS AFTER TOTAL KNEE ARTHROPLASTY ON HIS LEFT KNEE. S&N DEVICES CANNOT BE EXCLUDED AS TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED SERIOUS INJURY. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.

  Patient problems: Fibrosis

  MAUDE report 8468261 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A BILATERAL TKA WAS PERFORMED ON (B)(6) 2019. FIRST, THE RIGHT KNEE WAS IMPLANTED. AFTER THE IMPLANTATION OF RIGHT KNEE, THE DOCTOR FOUND THE PRODUCT FOR LEFT KNEE HAS BEEN IMPLANTED INTO RIGHT KNEE. LEFT KNEE TKA WAS PERFORMED ACCORDINGLY. THE DOCTOR DOES NOT CONFIRM IT PRODUCT FAILURE. NO DELAY WAS REPORTED.

  Patient problems: Injury

  MAUDE report 8306775 ↗
• InjurySep 12, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS NOTED WITH ARTHROFIBROSIS OF LEFT TOTAL KNEE WHICH WAS SOLVED WITH MANIPULATION UNDER ANESTHESIA ON (B)(6) 2012.

  Patient problems: No Code Available

  MAUDE report 6857323 ↗
• InjuryJun 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY LEFT MEDIAL MENISCUS SURGERY AFTER A PERI-PROSTHETIC FRACTURE AROUND INTERNAL PROSTHETIC LEFT KNEE JOINT WAS DISCOVERED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6622572 ↗
• InjuryMay 3, 2017Fracture; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO FEMORAL NECK FRACTURE THAT POSSIBLY OCCURED WITHIN 1 WEEK OF THE SURGERY.

  Patient problems: Failure of Implant; Hip Fracture; No Code Available

  MAUDE report 6540081 ↗

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