JOURNEY 74021163Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556422809), received between May 10, 2019 and May 29, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A REVISION TKA SURGERY WAS PERFORMED ON (B)(6) 2025 BECAUSE OF A LOOSE/MISALIGNED IMPLANT (ZIMMER BIOMET), THE PATIENT EXPERIENCED DIFFICULTY BEARING WEIGHT AND PAIN, AND THIS BECAME WORSE IN (B)(6) 2025. X-RAYS SHOWED LOOSE BODIES AND BONE SCAN FAVORED LOOSENING. TESTING WAS NEGATIVE FOR INFECTION AND ALLERGY TESTING WAS NEGATIVE WITH EXCEPTION OF NICKEL, BUT THE IMPLANT WAS NICKEL FREE. THIS ADVERSE EVENT WAS TREATED BY A LIDOCAINE INJECTION INTO BURSA ON (B)(6) 2025 AND A GAE WILL BE PERFORMED ON (B)(6) 2026. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD EXCEPT SEVERE PAIN WITH TKR.

  Patient problems: Joint Laxity; Pain

  MAUDE report 25331604 ↗
• InjuryMay 8, 2025Adverse 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 (B)(6) 2018, THE PATIENT EXPERIENCED AN ANTERIOR CRUCIATE LIGAMENT RUPTURE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE (1) JRNY II CR FEM OX NP LT SZ 3, THE (1) JRNY II XR BASEPLATE SZ 2 LT, THE (1) JRNY II XR INS XLPE LAT 1-2 LT 9MM, THE (1) JRNY II XR INS XLPE MED 1-2 LT 9MM, AND THE (1) GII OVAL RESURFACING PAT 32MM WERE EXPLANTED. PATIENT IS NOW RECOVERING.

  Patient problems: Damage to Ligament(s)

  MAUDE report 21990989 ↗
• InjuryOct 4, 2022Material Erosion; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Material Erosion; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA PROCEDURE ON (B)(6) 2020, THE PATIENT GOT PCL MALFUNCTION DUE TO FALLING AND FELT IMPINGEMENT BETWEEN FEMUR AND TIBIA. IN ADDITION, DURING X-RAYS IT WAS CONFIRMED THE JRNY II CR FEM OX NP LT SZ 3 AND JRNY II XR BASEPLATE SZ 2 LT WERE WEAR. A REVISION SURGERY WILL BE PERFORMED BUT THE DATE IS UNKNOWN.

  Patient problems: Damage to Ligament(s); Fall; Loss of Range of Motion

  MAUDE report 15535484 ↗
• InjuryApr 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14040814 ↗
• InjuryApr 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ASEPTIC LOOSENING IN HER KNEE. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE JOURNEY KNEE SYSTEM TO A LEGION SYSTEM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 14040605 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE THAT TOOK PLACE ON NOVEMBER THE 8TH, WITH A JOURNEY II CR FEM OXINIUM NP LEFT SIZE 3, THE PATIENT HAD MOBILITY LIMITATION IN THE KNEE. THE PATIENT WAS TREATED WITH AN UNSPECIFIED SURGERY. THE OUTCOME IS STILL RECOVERING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 11009205 ↗
• InjuryAug 28, 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 ON (B)(6) 2015 DUE TO INSTABILITY OF THE IMPLANT IN PATIENT'S LEFT KNEE. THE FEMORAL COMPONENT AND THE INSERT WERE EXPLANTED. THE OUTCOME OF THE EVENT IS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10468818 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A CONTRACTURE ON THE LEFT KNEE. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9832136 ↗
• InjurySep 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND DISLOCATION OF PATELLA BONE. FEMORAL COMPONENT AND INSERTS WERE EXCHANGED.

  Patient problems: Pain

  MAUDE report 9109439 ↗
• InjuryJun 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Fibrosis

  MAUDE report 8746896 ↗
• InjuryJun 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MUA WAS PERFORMED DUE TO STIFFNESS IN LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8681395 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED PAIN IN THE LEFT KNEE, WHICH WAS TREATED CONSERVATIVELY.

  Patient problems: Pain

  MAUDE report 8598929 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, K230653. One submission often covers many models, so check the product and lot details in each record.

• 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