JOURNEY 74027242Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00885556177662), received between Oct 10, 2017 and Dec 5, 2024 — classified as 27 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024Difficult to Insert; Peeled/Delaminated; Difficult to Insert; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING TKA SURGERY, A JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM COULD BE SEATED TO THE BASEPLATE AFTER SEVERAL ATTEMPTS. HOWEVER, AFTER INSERTING THE INSERT, IT WAS FOUND THAT THE FRONT PART OF THE INSERT WAS PEELED OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. THE DHR REVIEW AND COMPLAINT HISTORY REVIEW WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851091 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT CORI ASSISTED TKA WAS PERFORMED ON (B)(6) 2022, ON (B)(6) 2022 THE PATIENT EXPERIENCED INCREASING WOUND DEHISCENCE IN THE AREA OF THE DISTAL SURGICAL SCAR. ON (B)(6) 2022 THE PATIENT WAS HOSPITALIZED, AND A JOINT PUNCTURE AND A SECONDARY SUTURE WERE PERFORMED; RESOLVING THE ISSUE THE SAME DAY. NEVERTHELESS, THEN, ON (B)(6) 2022 A REVISION SURGERY WAS PERFORMED TO CHANGE THE JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 3 4 LEFT 10MM AND A DEBRIDEMENT WAS PERFORMED. BY (B)(6) 2022 THE PATIENT WAS DISCHARGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Wound Dehiscence

  MAUDE report 20334865 ↗
• InjuryNov 27, 2023Adverse 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 (B)(6) 2023, THE PATIENT EXPERIENCED INSTABILITY. A REVISION SURGERY WAS PERFORMED ON 06-NOV-2023 TO ADDRESS THIS ADVERSE EVENT, IN WHICH A SIZE 3-4 13MM BCS WAS INSERTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18209263 ↗
• MalfunctionOct 15, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE POSTERIOR LOCKING OF THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM COULD NOT SEAT ON THE BASEPLATE. THE SURGEON CHECKED THAT THERE WERE NO BONE CEMENT, SOFT TISSUE AND OTHER INCLUSIONS ON THE BASEPLATE. THEN, THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM WAS USED AS ALTERNATIVE, BUT SAME INSERTION PROBLEM OCCURRED. FINALLY, ANOTHER 9MM WAS ABLE TO FULLY SEAT INTO THE JOURNEY TIBIA BASE NP LT SZ 3 TO COMPLETE THE SURGERY. THE PROCEDURE WAS DELAYED ONE HOUR. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612450 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CORI ASSISTED TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A WOUND DEHISCENCE ON LEFT KNEE. THIS ADVERSE EVENT WAS TREATED BY A JOINT PUNCTURE ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. IT IS POSSIBLE THAT ANY OF THE COMPONENTS OF THE REAL INTELLIGENCE CORI MAY HAVE CAUSED OR CONTRIBUTED TO THE DEHISCENCE, OR MAY HAVE BEEN A GENERAL COMPLICATION OF CORI-ENABLED SURGERY.

  Patient problems: Wound Dehiscence

  MAUDE report 15535455 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA, A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM WITH THE JRNY II BCS CNSTRD ART ISRT 3-4 LT 12M BECAUSE OF LIGAMENT LAXITY OF THE LCL. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 11887068 ↗
• InjuryApr 29, 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) 2020, THE PATIENT EXPERIENCED A LIMITED ROM. THE SURGEON SAYS THAT THE DEVICES WERE NOT DEFECTIVE. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE JRNY II BCS FEMORAL OXIN LT SZ 4 (CASE: (B)(4)), GNS II RESURF PAT 35MM (CASE: (B)(4)) AND THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM (CASE: (B)(4)). THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 11744238 ↗
• InjuryOct 30, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE THE JOURNEY II BCS XLPE ART ISRT SIZE 3-4 LEFT 10MM DID NOT SEAT FULLY ONTO THE BASEPLATE. THE INSERTER CONNECTION POCKET WHICH IS LOCATED ON THE ANTERIOR OF INSERT, WAS DAMAGED BECAUSE THE INSERT WAS TRIED TO BE SET ONTO THE BASEPLATE REPEATEDLY. FINALLY THE BACK-UP, DIFFERENT SIZE, WAS UTILIZED AND COMPLETED THE SURGERY. SURGERY WAS DELAYED FOR NO LONGER THAN 30 MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10760135 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED BECAUSE THE PATIENT PRESENTED AN INFECTION AND FEVER. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 10740492 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED BECAUSE THE PATIENT PRESENTED AN INFECTION AND PAIN. THE SURGEON SAYS THE DEVICES WERE NOT DEFECTIVE. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10683946 ↗
• InjuryOct 9, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY THE DOCTOR ATTEMPTED TO LOCK THE JOURNEY II ARTICULAR INSERT SIZE 3-4 LEFT 9 MM ONTO THE PLATE TIBIAL BASE PLATE NONPORUS LEFT SIZE 3, BUT COULD NOT LOCKED WELL. AN ALTERNATIVE INSERT WAS TRIED THE JOURNEY II ARTICULAR INSERT SIZE 3-4 LEFT 10 MM BUT NEITHER COULD LOCK WELL. FINALLY THE DOCTOR INSERT THE JOURNEY II ARTICULAR INSERT SIZE 3-4 LEFT 9 MM BY HITTING HIM WITH A HAMMER AND CONSIDERED THE INSERT WAS SETTLED ONTO THE BASE PLATE. THERE WAS A 40 MINUTE DELAY FOR THIS EVENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10657744 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY OF THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM. IT IS UNKNOWN THE OUTCOME OF THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10632385 ↗
• InjurySep 13, 2020Adverse 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, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. A REVISION SURGERY WAS PERFORMED TO TREAT IT: JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 3-4 LT 10MM WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10526112 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO SUSPECTED INFECTION. THE INSERT WAS CHANGED FROM A SIZE 10 (74027242, 19CM23381) TO SIZE 11 (74027243, 19KM19863). PRIMARY ON (B)(6) 2020, REVISION ON (B)(6) 2020. PROCEDURE: TKA.

  Patient problems: Injury

  MAUDE report 10193747 ↗
• InjuryJun 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER TKA PROCEDURE, A REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED INFECTION. NO DELAY. THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM WAS REPLACED USING A S&N BACKUP DEVICE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10117318 ↗
• InjuryMar 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY. THE INSERT WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 9857704 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION CAUSED BY A FALL AND AN OPENED WOUND. THE ONLY THE POLY WAS REMOVED. NO FURTHER INFORMATION AVAILABLE YET.

  Patient problems: Unspecified Infection

  MAUDE report 9313363 ↗
• MalfunctionOct 3, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING IMPLANTATION, SURGEON HAD DIFFICULTY IMPLANTING THE DEVICE. BACK-UP DEVICE WAS USED. DELAY OF 45 MINUTES INVOLVED. NO PATIENT INJURIES. DEVICE WILL BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9151840 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE ARTHROFIBROSIS AND REQUIRED MANIPULATION UNDER ANESTHESIA AND ASPIRATION.

  Patient problems: Fibrosis

  MAUDE report 8834601 ↗
• 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 8787793 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED, 2-4 WEEKS POST OPERATIVE, PATIENT WAS IN REHAB AND WHEN REACHING FOR WALKER TO GET UP OFF TOILET HEARD A CRACKING SOUND. HER DISTAL FEMUR BROKE ABOVE THE FEMORAL COMPONENT, PATIENT WAS HOSPITALIZED, THE IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER BLOCKS WERE IMPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8660946 ↗
• 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 8468262 ↗
• InjuryMar 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ONGOING PAIN, SWELLING AND EFFUSIONS AFTER A POST-OPERATIVE FALL.

  Patient problems: Pain; Swelling

  MAUDE report 8452512 ↗
• InjuryMar 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. INSERT WAS EXCHANGED. OTHER IMPLANTS WERE RETAINED.

  Patient problems: Unspecified Infection

  MAUDE report 8399084 ↗
• InjuryJan 28, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIAL BASEPLATE. INSERT POLY WAS ALSO EXPLANTED.

  Patient problems: Injury

  MAUDE report 8282970 ↗

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