JOURNEY 74027281Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885556178317), received between Nov 9, 2017 and Mar 24, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 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.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED EARLY INFECTIONS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24682508 ↗
• InjuryFeb 25, 2026Fracture

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE ON AN UNKNOWN DATE, THE PATIENT SUFFERED A TRAUMATIC SURFING EVENT. THIS RESULTED ON BROKEN JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM THAT WAS EXPLANTED ON A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2026. PATIENT IS REPORTEDLY, WELL. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24442520 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED IN (B)(6) 2024, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXCHANGE THE JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM AFTER A WASHOUT DUE TO INFECTION. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Medical device site infection

  MAUDE report 23914589 ↗
• InjuryDec 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED A PATELLA PAIN DUE TO LACK OF POSTERIOR SLOPE ACCORDING TO PRE-OP X-RAYS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM WAS EXCHANGED. THE PEG WAS BROKEN. PATIENT'S CURRENT HEALTH STATUS IS NORMAL.

  Patient problems: Pain

  MAUDE report 23829771 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM WAS IMPLANTED ON (B)(6)2023, THE PATIENT FELL AND THE SURGEON BELIEVES THIS LED TO KNEE LOOSENING. ON (B)(6)2024 A POLY SWAP WAS PERFORMED, INSERTING A 13MM POLY INSERT IN ORDER TO CORRECT THE PROBLEM. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Joint Laxity

  MAUDE report 20819178 ↗
• InjurySep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED IN 2014, THE POST ON A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM FRACTURED AND WAS FLOATING IN THE PATIENT'S KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE INSERT WAS REPLACED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20256397 ↗
• InjuryAug 27, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT FELT A POP WHILE CHANGING CLOTHS, HIS KNEE STARTED TO HURT AND FELT UNSTABLE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Joint Laxity

  MAUDE report 20076147 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOW DATE, THE PATIENT HAD AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM AND A GII OVAL RESURFACING PAT 38MM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 19558924 ↗
• InjuryApr 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED PAIN AND SWELLING. BILATERAL KNEE ASPIRATION AN STEROID INJECTION WAS CONDUCTED SEVERAL TIMES. BONE SCANS CONFIRMED LARGE JOINT EFFUSION AND PATELLAR MALTRACKING, FOR WHICH, ON (B)(6) 2018, BILATERAL KNEE RELEASE WAS PERFORMED TO ADDRESS THIS KNEECAP POSITIONING PROBLEM. IN ADDITION, IT WAS LATER CONFIRMED THAT THE JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM BROKE OFF. THIS COMPONENT WAS FLOATING AROUND ALONG WITH PLASTIC FRAGMENTS FOR AN UNDETERMINED AMOUNT OF TIME. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INSERT WAS REMOVED AND REPLACED WITH ONE SIZE LARGER. PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Failure of Implant; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 19052088 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID.: ORUS-JOURNEY II BCSMULTI-PMCFU; SUBJECT ID: (B)(6); AE NO.: AE04. IT WAS REPORTED THAT AFTER A TKR SURGERY, PERFORMED ON (B)(6) 2012, WHERE THE FOLLOWING DEVICES WERE IMPLANTED: JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8 , JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 7-8 LEFT 9MM , JOURNEY TIBIAL BASEPLATE NONPOROUS LEFT SIZE 8 AND GENESIS II RESURFACING PATELLA 38MM. ON (B)(6) 2012 THE PATIENT PRESENTED A LYMPHEDEMA ON THE LEFT LEG (WHERE THE DEVICES WERE IMPLANTED), ADVERSE EVENT WAS TREATED WITH PHYSICAL THERAPY BUT WAS NOT RESOLVED. PATIENT DIED OF MYELODYSPLASTIC SYNDROME ON (B)(6) 2018, THIS DEATH CAUSE IS NOT RELATED TO THE IMPLANTED DEVICES.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12295078 ↗
• MalfunctionJun 18, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA, A JOURNEY TIBIA BASE NP LT SZ 7 DID NOT SEAT INTO TIBIA BASE. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY, WITH AN AVAILABLE SMITH AND NEPHEW BACK UP DEVICE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028730 ↗
• InjuryMar 8, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT COMPLAINED OF PAIN. A REVISION SURGERY WAS CONDUCTED TO ADDRESS THIS EVENT: THE SURGEON NOTICED THAT THE PATELLA WAS LOOSE AND THE KNEE WAS ALSO MEDIALLY LOOSE. THE PATELLA WAS BONE-GRAFTED AND A NEW THICKER INSERT WAS IMPLANTED. THE PATIENT¿S CURRENT STATUS OF HEALTH IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11441084 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVERAL PATIENTS PRESENT PATELLOFEMORAL PAIN. LOW PATELLAR TILT AND LATERALIZATION OF PATELLA. PATELLAR MALTRACKING. REVISION SURGERY WAS PERFORMED ON SEPTEMBER 16TH. THE PATELLA WAS RESURFACED AND NO COMPONENT WAS REMOVED.

  Patient problems: Pain

  MAUDE report 9881341 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A JOURNEY BCS CASE DONE WITH NAVIO SYSTEM, UPON CLOSING THE PATIENT, RANGE OF MOTION TEST WAS RUN AND A CLICKING SOUND WAS HEARD. DOCTOR REOPENED THE PATIENT AND TRIED TO CORRECT ISSUE WITH NO SUCCESS. CAUSE OF THE SOUND IS STILL UNKNOWN.

  Patient problems: Injury

  MAUDE report 8704305 ↗
• InjuryFeb 19, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DR. PERFORMED A LEFT KNEE REPLACEMENT ON HIS PATIENT ON THE (B)(6) 2018. SHE COMPLAINED OF PERSISTENT PAIN AND STIFFNESS AND DR. DIAGNOSED HER WITH SEVERE ARTHROFIBROSIS. HE TOOK HER BACK TO THEATRE ON (B)(6) 2019 AND REVISED THE FEMORAL COMPONENT TO ONE SIZE SMALLER AND EXCHANGED THE INSERT. NO MORE INFORMATION SHOWN.

  Patient problems: Pain

  MAUDE report 8351409 ↗
• InjuryFeb 5, 2019Break; Break

  IT WAS REPORTED THAT POLY POST BROKE OFF REQUIRING TO BE REVISED. THEREFORE, NO BACKUP DEVICE REQUIRED AND NO DELAY RECORDED.

  Patient problems: Injury

  MAUDE report 8307001 ↗
• InjuryDec 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF THE INSERT WAS PERFORMED DUE TO KNEE CONTRACTURE. THERE IS NO DAMAGE BUT ADHESION OF THE SOFT TISSUE ON THE INSERT . THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE.

  Patient problems: No Code Available

  MAUDE report 7155324 ↗
• InjuryNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT LOST RANGE OF MOTION DUE TO ARTHROFIBROSIS AFTER TKA AND UNDERGO MANIPULATION UNDER ANESTHESIA TO REGAIN ROM.

  Patient problems: Injury

  MAUDE report 7042441 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IRRIGATION AND A DEBRIDEMENT WITH POLYETHYLENE EXCHANGE IN THE LEFT KNEE DUE TO LEFT KNEE ARTHROFIBROSIS AND INFECTION. THE TIBIAL INSERT COMPONENT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 7017572 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO LEFT KNEE PAIN AND SWELLING.

  Patient problems: Pain; Swelling

  MAUDE report 7015641 ↗

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