JOURNEY 74027251Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556179369), received between Dec 1, 2017 and Mar 3, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Fracture

  IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED A PEG FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 5 6 RT 9MM WAS REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24502785 ↗
• InjuryOct 29, 2024Adverse 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) 2024, THE PATIENT FELL WHILE CHOPPING WOOD. A REVISION SURGERY TOOK PLACE ON (B)(6) 2024 DUE TO FEAR OF INFECTION (INFECTION NOT CONFIRMED AT THIS TIME) AND THE JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM WAS EXPLANTED. PATIENT STATUS IS UNKNOWN.

  Patient problems: Fall

  MAUDE report 20558049 ↗
• InjuryJun 11, 2024Adverse 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 PAIN. DURING THE PRIMARY SURGERY, THE PATELLA WAS NOT RESURFACED. TO ADDRESS THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE PATELLA WAS RESURFACED, AND ONE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM WAS EXCHANGED FOR A 10MM INSERT. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 19515547 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS RESOLVED BY REVISION SURGERY ON (B)(6)2024, DURING WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM WAS EXCHANGED. THE FEMORAL COMPONENT, TIBIAL BASEPLATE, AND PATELLA COMPONENT REMAINED IMPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 18961988 ↗
• InjuryDec 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY PERFORMED ON (B)(6) 2023 IN WHERE A JOURNEY II BCS FEMORAL, JOURNEY TIBIAL, JOURNEY II BCS INSERT, GENESIS II PATELLA WHERE IMPLANTED, A REVISION SURGERY WAS PERFORMED DUE TO INFECTION ON (B)(6) 2023. THE INSERT WAS EXCHANGED TO JOURNEY II BCS. THE FEMORAL COMPONENT, TIBIAL BASEPLATE AND PATELLA COMPONENT WERE REMAINED. THE SURGEON DOESN'T THINK PRODUCTS FAILURE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18423041 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2021, THE PATIENT REQUIRED SOFT TISSUE REPAIR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH A JOURNEY II BCS ARTICULAR INSERT SIZE 5-6 RIGHT 9MM WAS REPLACED.

  Patient problems: Damage to Ligament(s); Fall; Insufficient Information

  MAUDE report 14079910 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY AND A JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9 MM WAS SWAPPED OUT WITH ONE OF THE SAME SIZE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12908748 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TWO WEEKS OF A PERFORMED SURGERY, THE PATIENT WOUND OPENED UP. THE COMPLICATION WAS ADDRESSED VIA A REVISION SURGERY ON (B)(6) 2021. A JRNY II BCS XLPE ART ISRT SZ 5-6 RT 9MM WAS EXPLANTED AND REPLACED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Wound Dehiscence

  MAUDE report 11896316 ↗
• InjuryApr 5, 2021Adverse 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 SWELLING AND INFECTION. THE SURGEON SAID THAT THE DEVICES WERE NOT DEFECTIVE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 11616786 ↗
• InjuryOct 2, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM DISASSEMBLY OF THE INSERT. A REVISION SURGERY WAS PERFORMED IN ORDER TO REVISE THE INSERT AND REPLACE IT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10618830 ↗
• InjuryJul 3, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING TKA SURGERY THE SURGEON WAS UNABLE TO GET THE INSERT TO SEAT PROPERLY, THIS HAPPENED INSIDE THE PATIENT. A SECOND S&N INSERT FROM THE SAME FAMILY AND SIZE WAS OPENED AND WORKED FINE. THE SURGEON HAD TO REMOVE BONE AND TISSUE TO SEAT PROPERLY THE OTHER INSERT. THERE WAS NO DELAY TO THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10230722 ↗
• InjuryJan 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN, ANASTOMOTIC LEAKAGE AND FEELING OF ILLNESS.

  Patient problems: Injury; Pain

  MAUDE report 9652809 ↗
• InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PERSISTENT ANTEROLATERAL KNEE PAIN AFTER TKA RIGHT. LATERAL FACETECTOMY AND LATERAL RELEASE TKA RIGHT WAS PERFORMED WITH NO DEVICE CHANGE.

  Patient problems: Pain

  MAUDE report 8536062 ↗
• InjuryApr 4, 2019Material Separation; Material Separation

  MANIPULATION UNDER ANESTHETIC - AS A CONSEQUENCE OF, KNEE GAVE WAY WHIST PERFORMING SQUATS IN THE POOL, CAUSING SIGNIFICANT PAIN. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.

  Patient problems: Pain

  MAUDE report 8483545 ↗
• InjuryJan 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED AN IT BAND SYNDROME AND RIGHT PATELLA FEMORAL CLUNK CREPITATION FOR WHICH A KNEE ARTHROSCOPY WAS PERFORMED. NO REVISION REQUIRED. NO ADDITIONAL INFORMATION SPECIFIED.

  Patient problems: Injury

  MAUDE report 8260708 ↗
• 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 7846931 ↗
• InjuryJun 4, 2018Adverse 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. THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7566765 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISED WAS PERFORMED DUE TO STIFFNESS AFTER A RIGHT TKA.

  Patient problems: Injury

  MAUDE report 7075086 ↗

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